B. Braun Medical Inc.Requisition ID
B. Braun Medical Inc# of Openings
8AM to 5PMSite
With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.
U.S. Facilities and Operations:
Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.Responsibilities
In this position you will focus on the following:
- Collaborate with business and technical teams to create an enterprise-wide strategy and vision for how product-related data will be governed and flow across systems.
- Design, document and maintain data processes and flows across Master Data Management (MDM) and Product Lifecycle Management (PLM) systems.
- Assist with business process mapping, data modeling, data mapping, and data visualization for product-related data initiatives.
- Ensure that Master Data Management (MDM) and Product Lifecycle Management (PLM) systems remain validated and compliant.
- Develop and measure metrics - focused on Data Analytics.
- Ensure data pool requirements meet compliance with global standards and industry requirements such as GS1 data synchronization via GDSN, FDA submissions for UDI / GUDID (via 1WorldSync), and HL7.
The Sr. Project Manager, Project Management Office will lead the planning and execution of diverse, business critical and challenging projects or departmental assignments supporting BBraun US Operations. This role will manage cross-functional team resources throughout the project life cycle, and is accountable for meeting the agreed upon goals of the project, including the project schedule and budget, as well as the quality (e.g., scope and performance) of the project deliverables.Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Partner with various cross-functional team members, suppliers, external service providers and other internal and external stakeholders as necessary, to drive project performance aligned with projects' objectives.
- Prepare business cases for proposed new product development projects or capital engineering projects
- Drive successful implementation and management of assigned strategic capital projects focused on advanced product and manufacturing technologies, through project's entire lifecycle. Oversees day to day management of the project(s).
- Manage costs to stay within budget constraints with responsibility for cost estimation, budgeting, forecasting and management of contingency and allowances, cash flow etc.
- Manage project scheduling, defines project execution strategies, project planning
- and scheduling practices, coordination of project activities, and schedule change management techniques.
- Lead scope development, finalization, stakeholder alignment, scope change management.
- Ensure the completeness and quality of work packages and project deliverables.
- Monitor and confirm organizational adherence to policies, procedures, regulations and standard work.
- Coordinate and align priorities and resources, as well as drives team engagement and motivation.
- Manage vendor relationships relevant to project throughout the life cycle, including procurement processes, contract negotiations, and vendor/ contractor performance management.
- Proactively identify, manage and report to key stakeholders any risks to cost, schedule, scope or intended use of the project or its business case.
- Ensures regular communications regarding project updates to key stakeholders on project goals, objectives, priorities, plans, financials, schedules, issues, risks and metrics.
- Ensures operation in accordance with company policies and procedures, local regulations, FDA regulations, ISO standards, and Canadian Medical Device Regulation (CMDR).
Qualifications Expertise: Qualifications - Experience/Training/Education/EtcRequired:
- Demonstrated expertise in Project Management tools, techniques, culture, software applications, such as Microsoft Project.
- Experience in leading and managing by influence people in multi-disciplinary teams and in partnering with stakeholders for building alignment and for driving a change.
- Strong people, leadership, communication skills to influence people across various organizational levels, cultural diversity and/ or geographically dispersed
- Ability to effectively handle conflict through proactive action and direct and timely communication
- Knowledge of Continuous Improvement and Quality Management techniques such as Six Sigma, Lean, TQM, Deming, etc.
- Knowledge of Quality Systems, GMP, FDA, GCP
- Strong analytical skills, decision-making capabilities and computer skills tools/solution (various PC applications, MS Project, IT solutions and Sharepoint/Enterprise solutions application)
- Strong Financial acumen - Ability to pull together financial justifications
- Bachelor's Degree in Engineering or Science with 10+ years experience in Life Sciences Industry or equivalent
- 7+ years experience with program management or project management in FDA regulated environment
- Experience managing Capital Engineering or Product Development projects across their life cycle in the Pharmaceutical, Biotech or Medical Device industry
- PMI PMP Certification
- Experience managing a product development and commercialization project requiring regulatory submission
- Experience with various types of manufacturing processes core to the business of BBM, such as solution preparation and filling of sterile solutions, packaging and plastics manufacturing
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.Other Responsibilities: Other Duties:
- 20-30% of Domestic and International travel
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.