9 jobs found in center valley

Aesculap Implant Systems Project Manager I, RA US-PA-Center Valley Job ID: 2019-15493 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aesculap Implant Systems Overview Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: The Project Manager I, Regulatory Affairs is primarily responsible for multiple product development projects, and potentially multiple product development programs, from the Regulatory Affairs perspective. Responsible for obtaining and maintaining AIC and AIS product registrations, clearances and approvals through the US Food and Drug Administration (FDA). In this pursuit, the department manages projects and proactively work with Marketing, Research and Development (R&D), Medical and Scientific Affairs (MSA), and other cross-functional groups throughout the product development process. Regulatory Affairs plays a critical role in Product Life Cycle Management (PLM), from concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the US Food and Drug Administration, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector. Principal Duties Responsibilities: Serves as Regulatory Affairs lead on cross-functional product development project teams. Works with Marketing, R&D, MSA and QA to develop effective regulatory strategies. Facilitates the generation and provision of information for product submissions, and helps to drive the product development process. Reviews information (e.g. plans, protocols, reports) for suitability for submission. Drafts Letters-to-File, 510(k), De Novo, IDE and PMA submissions. Directly interacts and negotiates with FDA to ensure product clearances/approvals. Ensures the timely registration/clearance/approval of products. Resolves regulatory issues and develops solutions to a variety of problems of critical scope and complexity with little or no supervision. Supports post-approval activities. Reviews and approves labeling, packaging, advertising and promotional information for regulatory compliance. Provide regulatory input for product recalls and recall strategies. Anticipates regulatory obstacles and emerging issues throughout the product life-cycle and develops solutions with other departments. Actively participates in various industry groups (e.g. AdvaMed, OSMA, AAMI). Keeps abreast of and shares information of changes to the regulatory and competitive environment. Interacts with FDA, industry groups (e.g. AdvaMed, OSMA), corporate partners, customers and vendors. Assists RA staff and cross-functional teams to aid in the development of Regulatory strategies to ensure timely product registrations, approvals and clearances. Reviews submissions to the FDA. Manages and disseminates Regulatory Intelligence and training to RA staff and other stakeholders. Oversees the review of product labeling, packaging, advertising and promotional information. Assists Quality Assurance with FDA inspections and internal/ external audits. Must comply with applicable regulations, as stated in Quality Manual. Must embody the Company’s Vision, Mission and Values. Other duties as assigned. Secondary / peripheral job functions: Supports the Head of Regulatory Affairs, as required / when requested. Performs other duties or special projects as assigned by Regulatory Affairs Management/Leadership. Requires excellent written, oral and interpersonal communication skills. Computer skills in Windows, MS Word, Excel and Power Point. Must be able to travel by automobile, train and airplane, and work occasional weekends. Supervisory Responsibilities: No direct supervisory responsibility. Provides coaching and mentoring to junior staff. May work in a supervisory role during absence of the Head of Regulatory Affairs. Job Specifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Qualifications Education/Experience: Bachelor of Science Degree in Engineering or Life Science -or- Associate of Science Degree Plus Significant Medical Device Regulatory Affairs Experience Minimum of 10 years of Regulatory Affairs experience in an FDA-regulated industry. Medical device industry experience highly preferred. Substantial experience directly interacting with the US FDA (e.g. meetings, negotiations). Practical knowledge of product development, product life cycle management, and design controls, medical device registration/clearance/approval, QSR and GMP desired. Practical experience with testing (e.g. bench testing, biocompatibility testing, etc.), spine and/or orthopedics desired. Regulatory Affairs Certification a plus. Project Management Certification a plus. Ability to anticipate changing regulations and business needs, and proactively work to change direction. Strong technical understanding of products, procedures, practices and associated medical terminology. Proficient in MS Office Suite. SAP experience preferred. Must be able to travel locally, domestically and internationally. Language and mathematical skills; reasoning ability: Language Skills: Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies and/or members of the business community. Ability to effectively present information to executive management, public groups and/or boards of directors. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability: Ability to define problems, collect date, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117975890

Aesculap Inc. Associate Product Manager - Laparoscopy US-PA-Center Valley Job ID: 2019-15613 Type: Regular Full-Time # of Openings: 1 Category: Marketing Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: Responsible for managing and implementing marketing activities for assigned product areas (Surgical Instruments) through research, strategic planning and implementation. Responsibilities: Essential Duties Works with senior marketing member to translate physical product characteristics into key positioning statements and competitive advantages for assigned product line. Works with Marketing Research Department to develop, analyze and maintain competitive profiles for products and companies including literature resources. Works with senior marketing member to develop and manage new product introduction process, including written product proposals, project management, all launch activities, line extensions and modifications. Works with senior marketing member to develop all marketing communications materials and promotional items (catalogs, brochures, press releases, and training materials) for assigned product line. Works with senior marketing member to conduct on-going research to define market needs (includes interfacing with hospital personnel, surgeons, nurses, and sales representatives, surgical observation, and literature review) to develop and maintain product lines. Identifies and implement new product styles, patterns, line extensions, deletions. Works with senior marketing member to develop, implement and update annual marketing plan for product line to maximize the company's position, as well as participates in the formulation and development of department’s strategic plan. Develops short-term product promotions. Evaluates pricing strategies and works with senior marketing member on implementation. Produces on a monthly basis, accurate product sales forecasts in conjunction with Forecast Department and senior marketing person. Coordinates activities with members of various departments to implement the marketing plan (includes sales, operations, research and development, regulatory, quality assurance). Works with senior marketing member to distribute updates on products, the market, and competitive activities. Works with senior marketing member to create and maintain all training and in-service materials for product line and conducts product demonstrations and seminars to internal and external personnel as requested. Provides technical product support to the sales force, customer service and end user. Reviews materials with marketing and sales management. Coordinates participation at trade shows, workshops, meetings with customers, sales meetings and participates as required. Other duties may be assigned. Must comply with applicable ISO and FDA regulations as stated in our quality manual. Must embody the Company’s Vision, Mission and Values. Secondary or peripheral job functions: Must be able to travel domestically and internationally by air and car, and work occasional weekends. Must possess a valid government issued drivers license and passport. Requires excellent written and interpersonal communication skills. Computer skills in Windows, Excel, Power Point and word processing desirable. SAP experience highly desirable. Strong Excel and PowerPoint skills preferred. This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. Able to pass and maintain annual Vendor Credentials such that healthcare facilities allow entrance into patient care areas in direct association with marketing and selling of groups products. Ability to work on projects/assignments with minimal supervision and willingness to take the “next step” to drive to completion Must be a self-starter and able to work with little or no supervision and minimum daily interface with management Occasional overtime and weekend work may be required Requires exceptional organizational skill, ability to work under pressure, and ability to prioritize and handle multiple tasks Expertise: Knowledge & Skills Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Bachelor’s degree in Business, Marketing, Engineering or equivalent; 2+ years work experience Business to business marketing or product management experience preferred, but not required. Medical device product management experience preferred. Desired: N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117715252

Aesculap Inc. Project Manager, AIC Marketing US-PA-Center Valley Job ID: 2020-15687 Type: Regular Full-Time # of Openings: 1 Category: Marketing Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: Manages the commercialization aspects of key new products with responsibility for driving collaboration of cross-functional product commercial teams. Plays a key role in pioneering and establishing the culture of project management within the product commercialization process of Aesculap. The ability to organize, lead and motivate people toward the achievement of a common goal is a primary requirement for the position. Acts as the internal liaison between, marketing, manufacturing, RA/QA, sales management and engineering for the purpose of scheduling projects, driving the timely launch of projects, budgeting resources, and reporting on the progress of several projects that are simultaneously being prepared for commercialization. Additionally, engages externally with outside partners, such as Aesculap parent organization and testing laboratories, in conjunction with marketing, manufacturing, RA/QA, sales management and engineering to support commercialization efforts. Generally has no direct reports but will, on a specific project basis, direct efforts of engineers, technicians, designers and outside consultants. Responsibilities: Essential Duties Lead, manage and monitor the projects to achieve results according to the approved plan and time, cost and quality parameters. Collaborates and cultivates cross departmental relationships and competencies necessary for the successful commercialization of targeted projects. Define, coordinate and manage commercialization project team. Develops and maintains detailed project schedules and budgets for assigned projects Establish a clear stakeholder communication plan and provide executive level project summaries and deliver senior level status presentations. Assists in the creation of accurate forecasts for products and works cross functionally to ensure the delivery of those forecasts.   Facilitate the identification of project issues and align with program sponsors and stakeholders to bring forward a proposed risk mitigation action plan with options for resolution. Negotiate the allocation of resources to support the endorsed project plan Ensures design control requirements are met for project. Assists in improving and revising existing commercialization procedures and processes. Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company’s Vision, Mission and Values Other duties and responsibilities as assigned. Secondary or peripheral job functions: Must be able to travel domestically and internationally by air and car. Travel related to this position estimated as less than 10%. Work occasional evenings/weekends due to projects, Must possess a valid government issued drivers license and passport. Able to pass and maintain annual Vendor Credentials so that healthcare facilities allow entrance into patient care areas in direct association with marketing and selling of groups products. Supervisory Responsibilities: Not Applicable Expertise: Knowledge & Skills Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Bachelor’s degree, preferably in health sciences, marketing, or business management related. MBA Preferred PMP certification preferred. 3-5 years’ experience with demonstrated project / program management expertise within a highly-regulated environment within the medical device, pharmaceutical or biotech industry. Demonstrated ability managing multiple projects, of varying complexity, within the specified guidelines, timeframes and budgets Demonstrated success in leading through influence, with the ability to achieve top performance from project teams Demonstrated ability to integrate information to build and implement solutions to organizational problems Results-driven leadership and management skills Excellent negotiating skills Excellent communication, presentation and influencing skills up, down and across the organization Highly flexible and adaptable. Diplomatic and tactful. Strong business, analytical and planning skills Creative thinking and proactive problem-solving skills Well-versed with project management tools, including MS Project and Excel. SAP experience a plus     Lean Six Sigma training/knowledge a plus Trained in Agile Project Management processes a plus Ability to travel based upon business needs (less than 10%) Desired : N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117715256

Aesculap Inc. Product Manager US-PA-Center Valley Job ID: 2020-15758 Type: Regular Full-Time # of Openings: 1 Category: Marketing Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: Responsible for managing and implementing marketing activities for assigned product areas through research, strategic planning and implementation. Responsibilities: Essential Duties Conducts on going research to define market needs (includes interfacing with hospital personnel, surgeons, nurses, and sales representatives, surgical observation, and literature review) to develop and maintain product lines. Identifies and implements new product styles, patterns, line extensions, deletions. Maintains inventory to include disposition of excess product and maintenance of marketing warehouse for individual line. Creates promotions to move slow-selling items. Identifies product and service opportunities to meet market needs. Develops, analyzes and maintains competitive profiles for products and companies including literature resources. Develops implements and updates annually the business plan to maximize the company's position, as well as participates in the formulation and development of department’s strategic plan. Develops short-term and long term product promotion strategies. Formulates effective pricing strategies. Produces accurate product sales forecasts in conjunction with Forecast and Planning Department and assists in maintaining it current on a monthly basis. Manages activities with members of various departments to implement the marketing plan (includes sales, operations, research and development, regulatory, quality assurance). Develops and manages new product introduction process, including written product proposals, project management, all launch activities, line extensions and modifications. Develops all marketing communications materials and promotional items (e.g. catalogs, brochures, giveaways, press releases, and training materials) for assigned product line. Distributes updates on products, the market, and competitive activities. Creates and maintains all training and in-service materials for product line and conducts product demonstrations and seminars to internal and external personnel as requested. Provides technical product support to the sales force, customer service and managed care. Coordinates participation at trade shows, workshops, meetings with surgeons and hospitals, sales meetings and participates as required. Performs special projects as assigned. Leads team projects and cross-functional assignments. Drives and controls R&D process with suppliers and OEM customers. Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company’s Vision, Mission and Values Other duties may be assigne Secondary or peripheral job functions: Must be able to travel domestically and internationally by air and car, and work occasional weekends. Must possess a valid government issued drivers license and passport. Requires excellent written and interpersonal communication skills. Computer skills in Windows, Lotus e-mail, Excel, Power Point and word processing desirable. SAP experience highly desirable. This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. Must comply with applicable ISO and FDA regulations as stated in the Quality Manual. Must embody the Company’s Vision, Mission, and Values. Supervisory Responsibilities: Support Associate Product Manager on projects, deliverables and development. Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Bachelor’s degree in Business, Marketing, Engineering or equivalent 4 – 6 years work experience, specifically in Marketing field MBA or advanced degree preferred At least 4 years in medical device product management. 2 years of business to business sales experience preferred. Language and mathematical skills; reasoning ability: Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117715262

Aesculap Inc. Senior Planner/Buyer US-PA-Center Valley Job ID: 2019-15654 Type: Regular Full-Time # of Openings: 1 Category: Other Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: Responsible for developing and implementing plans in the supply chain area (material procurement, forecasting, vendor selection and retention, expediting, analyzing and inventory management) for assigned hierarchies. Responsibilities: Essential Duties Planning, purchasing, supply chain management and coordination of material flow to meet customer Critical to Quality (CTQs) and profitability objectives Develop, monitor, and pursue tactical initiatives/projects with suppliers that meet corporate inventory management goals Responsible for being the primary Operations lead for the introduction of product line extensions, new products and product life cycle management for assigned materials Drives cost savings and quality improvements Ability to coach, supervise and/or mentor Planner/Buyer I and II teammates to maximize individual and team success Maintain established line fill rates and target inventory levels for part numbers and/or products assigned Lead continuous improvement teams to improve customer service, operations and/or inventory targets Successfully lead one or more MBO(s) (management by objectives) for the department and/or company Responsible for being the primary Operations lead for the introduction of product line extensions, new products and product life cycle management for assigned materials Participates in the Aesculap Gate Protocol Launch and Validation process for new products, ownership of Operation’s responsibilities of SAP product setups and support of initial stocking levels for assigned materials Participates in scheduled PAC meetings and reports to Operations leadership a scorecard of performance against tasks for an on-time and successful full product launch Leads the Sales & Operations Planning (S&OP) and/or Sales, Inventory & Operations Planning (SI&OP) meetings for assigned materials and/or product lines Develops and summarizes forecasts of anticipated demand using historical data and sales trends, SBA (Strategic Business Area) business plans, sales and marketing forecasts, and customer projections for assigned products Analyzes and maintains reorder point (ROP) for part numbers and/or product lines assigned Input and maintain the appropriate forecasts in SAP as needed Participates in the product life cycle management for evaluation and recommendation of product disposition to deplete the inventory and/or obsolescence of product being discontinued or phased-out Maintain purchasing information records (PIR) and material master (MM) in SAP Responsible for data integrity within SAP for assigned materials Requires frequent interaction with personnel in other departments to follow-up, expedite, and coordinate parts Prepare daily, weekly and monthly reports pertaining to current status of inventory and overall customer service level as needed Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must demonstrate the Company’s Code of Business Conduct; Vision, Mission and Values and Cultural Beliefs, daily Ability to travel domestic and overseas as necessary Other duties may be assigned Expertise: Knowledge & Skills Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Supervisory Responsibilities: Supervisory Responsibilities: May be assisted by entry or intermediate level personnel within the supply chain Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Bachelor’s degree with a major in materials management, supply chain, logistics, operations management required. Advanced degree preferred Minimum 8 years’ experience in progressive supply chain experience in Forecasting, Planning, Purchasing, Logistics, Operations, inventory management. Certification in APICS, ISM, or IBF preferred Minimum of 6 years’ experience in project management and/or continuous improvement Minimum of 6 years’ experience in SAP (or comparable ERP system) preferred Strong organizational and analytical skills Effective verbal and written negotiation and communication skills Proficient in Microsoft Office applications Ability to be a team player and work with minimal supervision Certification in Lean, Sigma, or continuous improvement or equivalent experience preferred Experience or knowledge of Kanban pull preferred Knowledge of computerized forecasting, planning, and purchasing techniques preferred Strong Excel and PowerPoint experience preferred Experience in medical device industry and FDA requirements, preferred Desired: N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117715267

Aesculap Inc. Corporate Paralegal US-PA-Center Valley Job ID: 2020-15844 Type: Regular Full-Time # of Openings: 1 Category: Legal Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: The Corporate Paralegal will be responsible for gathering, preparing and summarizing relevant materials in support of attorneys in the Legal Department and/or business clients. The Corporate Paralegal will maintain case files of new and existing complaints, perform legal research, draft correspondence, and prepare and edit legal contracts for attorney review, as well as assist with various projects as requested. Attention to detail and a heightened awareness to deadlines are required. Responsibilities: Essential Duties Prepare and review confidentiality agreements with attorney supervision Lead due diligence and document production projects Draft, issue and track all litigation holds impacting the Company Provide litigation support to attorneys Assist with management of trademark portfolio Review advertising and marketing materials to ensure compliance with the laws relating to copyright and trademark Draft and negotiate various Services Agreements and Photographic Image Agreements Follow up on action items with attorneys to ensure they are addressed and resolved Maintain corporate books and records as requested and ensure compliance with various state laws, internal and external auditor requirements, and company bylaws Prepare, facilitate, and administer letters, emails, and other related documents ensuring accurate grammar, spelling, content, and business formats Conduct legal research and drafting as requested Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company’s Vision, Mission and Values Other duties may be assigned Expertise: Knowledge & Skills Secondary or peripheral job functions: Requires excellent written and interpersonal communication skills Requires confidentiality and discretion Supervisory Responsibilities: N/A Language and mathematical skills; reasoning ability: Language Skills: Ability to read and interpret basic legal documents. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Associate’s or Bachelor’s degree (B.A.) Minimum two years paralegal or related experience. Paralegal certificate preferred Computer skills in Windows, Lotus e-mail, Excel, Power Point and word processing desirable. Desired: While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117715277

Aesculap Inc. SAP SD/SCM Applications Analyst US-PA-Center Valley Job ID: 2019-15244 Type: Regular Full-Time # of Openings: 1 Category: Information Technology Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: Configure and manage the SAP SD/SCM modules and related order-to-cash areas, Supply Chain Management, reporting systems, and other systems to support sales and order-to-cash business objectives and improve the operational efficiency and analysis of the sales organization. Responsibilities: Essential Duties Analyze, implement, support, and document optimal uses and configurations of the SAP SD/SCM Sales & Distribution module to support the business. Across the order-to-cash process, research, analyze, and evaluate present or proposed business procedures or problems to define the best SAP system solutions and map them to SAP Identify sales information and business requirements by interviewing and working with key business personnel. Configure systems to support these requirements. Provide maintenance, functional and transactional support to end-users for SAP and sales system usage. Analyze, troubleshoot and resolve business process or system application problems reported by end-users for these areas. Deliver SAP training programs for end-users for the SAP SD Sales & Distribution module and related areas. Represent the US division as our global competency center member for the SD/CRM competency center. Serve as a subject matter expert for the SD module. Analyze, implement, support, and document optimal uses and configurations of the Redwood Report2Web system and other sales related systems such as CRM tools and SFA sales force automation systems. Work with the business to implement, maintain, and administer field sales information systems and their integrations with SAP. Maintain, enhance and support the sales contract management system and other specialized sales areas within SAP. Implement analytics, scorecards, and oversight capabilities associated with the order-to-cash process. Improve the use and data integrity of information from SAP and BW reporting systems and other information technology tools used within the business. Support the sales division in sales and order-to-cash analysis. Work with the sales division to develop technical reports for collecting, analyzing and summarizing information and trends. Train end-users to utilize these reports. Develop SAP reports using ABAP, ABAP/Query, SIS, and BW to support business analysis and processes. Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company’s Vision, Mission and Values Secondary or peripheral job functions: Support the management of the sales and contracts organizations within the SAP Assist management with analyses of the market, competition, and company position in the market. Mentor sales SAP specialists (super users, reporting specialists and master data specialists). Support IT business initiatives. Investigate and determine potential solutions and enhancements for the business using SAP technologies, internet technologies, and other information technology tools. Maintain business and technical knowledge by attending educational workshops, reviewing publications, establishing personal networks, and participating in technical societies as appropriate. Establish position as an effective SAP contact for the Aesculap organization. Proactively develop relationships with Center Valley personnel, including management and end-users. Respond to the expectations and needs of Center Valley Build credibility and trust with Aesculap personnel. Establish position as an effective, contributing member of the Aesculap SAP Work within the Aesculap SAP organization to manage and deliver SAP and IT solutions for the business. Work with Aesculap SAP team members in a team-work oriented environment that supports sharing of information and opportunities, acting in a manner that benefits the company and provides for the overall success of the Aesculap SAP team. Openly share ideas and seek advice from colleagues. Develop comprehensive project plans for producing deliverables and meeting management expectations. Implement solutions according to project plans. Effectively communicate accomplishments and issues to management in a timely manner. Other duties may be assigned Expertise: Knowledge & Skills Language and mathematical skills; reasoning ability: Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: B.A./B.S. in engineering, computer science, or equivalent experience. Experience with SAP version 4.6C or greater. 7-15 years experience in performing SAP configuration and solution delivery within the SD module and related order-to-cash areas. SAP ABAP programming experience including the use of ABAP, ABAP-Query, Function Modules, BAPIs, Userexits, and SAPScript desired. SAP BW and SIS Sales Information System experience desired. Desired: N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117715240

Aesculap Inc. Prinicipal Quality Administrator US-PA-Center Valley Job ID: 2019-15491 Type: Regular Full-Time # of Openings: 1 Category: Quality Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: Responsible for implementing, maintaining and improving the Quality Vigilance System for all Aesculap US sites. Specifically, interactions with the Food and Drug administration with regards to corrections and removals. He/She will be instrumental in contributing to defining the direction and plans for recalls and ensuring the site is 21 CFR 806 complaint. Will lead recalls, Corrections and Removals. Also he/she will work directly with the Vigilance group to monitor possible recall needs. Must be comfortable exercising latitude in ensuring the site is compliant with the Aesculap Quality System, the FDA quality regulations and standards it is built on. Comfortable coaching all employees on the Aesculap Correction and Removal process and working professionally with others to reach understanding and agreements as necessary. Represents the company as a primary FDA Recall contact, comfortable communicating internally and externally as well as collaborating at various levels. This individual must be comfortable working autonomously in that much of their work will be completed with limited oversight. Responsibilities: Essential Duties Coordinates, and monitors FDA vigilance notifications and recall activities. Acts as the Quality representative for communication and interfacing with the FDA regarding Field Safety Notice and Recall Notifications. Coordinates and organizes Site Corrections and Removals (recalls). Expedites the coordination of activities for timely FDA reporting and interfaces with Supply Chain, Marketing, and Product Managers. Leads Health Hazard Assessment (HHA) and Health Hazard Evaluation (HHE) activities with collaboration from Regulatory Affairs, Product Managers, R&D Engineers, and the applicable OEM as part of Aesculap’s Risk Management Program. Ensures corrections, removals and recalls are managed effectively and efficiently. Support decision making for Health Hazzard Assessments, Vigilance Reporting, CAPA, and Recall based on analysis and trending of post-market data sources. Assists with onsite ISO and FDA inspections and maintenance of formal responses to findings. Coordinates, monitors, and analyzes trending of Recall data for Monthly Quality Data Review and Management Review Meeting (MRM) discussion. Acts as the lead and mentor for guidance of Aesculap on Corrections and Removal (Recalls). Ability to process complaints and MDRs as needed. Coordinates and monitors FDA vigilance notifications, recalls and Health Risk Assessment (HRA) and Health Hazard Evaluation (HHE) activities. Acts as the Quality representative for communication with the FDA regarding Field Safety Notice, Recall Notifications and inventory recovery reconciliation. Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company’s Vision, Mission and Values Other duties may be assigned Secondary or peripheral job functions: Assists in the assembly of technical files for the FDA, and other Regulatory Bodies, as applicable. Assists and coaches Aesculap employees on Correction and Removal regulations. Maintains Quality Recall Dashboard metrics for input into Management Reviews. Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others. Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes. Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices. Expertise: Knowledge & Skills Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors. Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability : Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Bachelor of Science required. Life Sciences and/or Engineering degree preferred. 6-10 years’ experience in Medical Device Quality Compliance with BS/BA or 4 years with MS/MA required. Recall experience to include submission of 806 reports required. Knowledge of complaint/MDR processing using FDA Webtrader software preferred. Superb conflict management skills. Knowledge of Electronic Submission of 806 Reports for Corrections and Removals Experience interfacing with Regulatory bodies- FDA/ISO Must have excellent working knowledge of FDA Regulations Requires computer skills (Word, PowerPoint, Lotus Notes, Excel Charts/Graphs, SAP, BDocs) . Demonstrated excellent written and oral communications with the ability to influence and interface across the organization Advanced presentation skills Experience with FDA and ISO 13485 and other applicable standards. Must have excellent interpersonal, facilitation, negotiation, consensus building, conflict resolution and organizational skills. Experience interfacing with FDA/ISO personnel. Inspection front room experienced preferred. Demonstrated excellent written and oral communications with the ability to influence and interface across the organization. Advanced presentation skills using PowerPoint. Desired: N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 30 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117715246

Aesculap Inc. Corporate Paralegal US-PA-Center Valley Job ID: 2020-15844 Type: Regular Full-Time # of Openings: 1 Category: Legal Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: The Corporate Paralegal will be responsible for gathering, preparing and summarizing relevant materials in support of attorneys in the Legal Department and/or business clients. The Corporate Paralegal will maintain case files of new and existing complaints, perform legal research, draft correspondence, and prepare and edit legal contracts for attorney review, as well as assist with various projects as requested. Attention to detail and a heightened awareness to deadlines are required. Responsibilities: Essential Duties Prepare and review confidentiality agreements with attorney supervision Lead due diligence and document production projects Draft, issue and track all litigation holds impacting the Company Provide litigation support to attorneys Assist with management of trademark portfolio Review advertising and marketing materials to ensure compliance with the laws relating to copyright and trademark Draft and negotiate various Services Agreements and Photographic Image Agreements Follow up on action items with attorneys to ensure they are addressed and resolved Maintain corporate books and records as requested and ensure compliance with various state laws, internal and external auditor requirements, and company bylaws Prepare, facilitate, and administer letters, emails, and other related documents ensuring accurate grammar, spelling, content, and business formats Conduct legal research and drafting as requested Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company’s Vision, Mission and Values Other duties may be assigned Expertise: Knowledge & Skills Secondary or peripheral job functions: Requires excellent written and interpersonal communication skills Requires confidentiality and discretion Supervisory Responsibilities: N/A Language and mathematical skills; reasoning ability: Language Skills: Ability to read and interpret basic legal documents. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Associate’s or Bachelor’s degree (B.A.) Minimum two years paralegal or related experience. Paralegal certificate preferred Computer skills in Windows, Lotus e-mail, Excel, Power Point and word processing desirable. Desired: While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI117533968