Program Manager- Medical Device R& D
Program Manager- Medical Device R&D
Job Category: Engineering – Other Engineering
Reporting to the Director of Program Management, R&D, the Senior Core Team Leader Role (aka Program Manager) is responsible for leading large, complex product development efforts that consist of one or more projects under development for a specific platform or business segment. This person will lead all aspects of development on their program, which may cover from the start of the Concept or Definition Phase through successful completion of the Launch Phase and Program closeout. The candidate will also be responsible for leading the team to achieve cost, schedule, and performance goals of the project or program, including commercial success.
Duties and Responsibilities:
- Defines customer requirements.
- Spends time with customers/end-users and invests in understanding the customer environment.
- Architects or refine the high-level product concept to fulfill the customer requirements.
- Leads the creation and follow up on the cross-functional project plan, including budget, resource and capex planning, to fulfill the product concept.
- Resolves personal / team conflicts and program / functional conflicts.
- Executes successful commercial, design, and business project reviews.
- Makes Pipeline Decision Team (PDT) aware of and proposes solutions to unanticipated or potential issues/concerns as they are known.
- Minimizes barriers to progress, raising significant hurdles to senior management’s attention for resolution.
- Provides work direction to assigned cross-functional Core Team Members.
- Aligns and manages all cross-functional activities to deliver the product on time and on budget per contract while meeting agreed upon technical, operational, business and customer requirements.
- Works with Finance and Marketing Core Team Members to develop the financial analysis of the project/program and ensures the ability to meet key project value drivers.
- Responsible for ensuring compliance with quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
- Responsible for ensuring compliance with all local, state, federal, and safety regulations, policies, and procedures.
Qualifications:
- Bachelor’s Degree in a technical field required.
- Master’s Degree in a technical field or MBA highly preferred.
- 10+ years’ experience in technology or product development in a regulated industry, with a medical device, preferred.
- 8+ years of experience leading teams to develop complex line extensions or new products. Additional and Preferred Qualifications:
- Advanced technical judgment and technical leadership skills.
- Strong interpersonal, influence and communication skills Learning agility and critical thinking Demonstrated capability in project planning and cross-functional leadership.
- probabilistic modeling strongly preferred.
- Advanced problem-solving skills Strong understanding of structured product development processes, regulatory and quality requirements.
- Strong fit with values Successful track record of delivering products to market or developing commercially viable