Overview In this role, you will lead engineering and research activities to bring medical device products from prototype to commercial sale. You will collaborate with contract design and manufacturing partners, align development with program requirements, and manage risk, validation, and regulatory compliance. You will own the product development lifecycle, interface with clinical and commercial teams, and drive data-driven problem solving. This is a hands-on leadership position that shapes product strategy and manufacturing readiness at scale.
Responsibilities- Lead product development activities at contract design & manufacturing facilities
- Develop project plans with goals, strategy, resources, and risk identification
- Oversee concept, development, verification, and launch phases
- Create validation and verification strategies for engineering projects
- Ensure deliverables comply with Quality System Requirements and Industry Standards
- Coordinate design development and manufacturing plans with outside vendors and manage those vendors
- Provide clear communication to internal teams and escalate challenges to senior management
- Offer medical device development expertise to resolve engineering issues
- Identify next-generation product changes and refine the product portfolio
- Interface with physicians, marketing, sales, and clinical teams to integrate customer inputs throughout the development cycle
Key requirements- Bachelor in Mechanical Engineering (or Engineering discipline)
- 5+ years in medical device industry (8+ desirable)
- 2+ product development and manufacturing projects completed from prototype to commercial sale
- Experience with disposables and adhesive-based products desirable
- Quantitative modelling skills for structural analysis (finite element)
- Test and validation protocol development for device specification verification
- Excellent project management skills
- Expertise in Product Development cycle including design review, risk management, and testing/validation planning
- CAD drawing software (Solid works, Rhino) for vendor submissions
- Background in manufacturing of medical devices
- Clear communication
- Data-driven issue resolution
- Strong project management
- Quantitative modelling (finite element)
- Validation and verification planning
- Product Development cycle management
