The Technical Lead, Product Development provides technical leadership for medical-device and combination-product prototyping and feasibility activities. This role applies expertise in mechanical, plastic, electrical, software, human factors, and usability engineering to develop integrated product solutions. The Technical Lead resolves technical challenges, influences cross-functional decisions, and considers the impact of development activities on design controls, verification and validation, risk management, and regulatory submissions.
Responsibilities
- Lead prototyping and feasibility activities for medical-device and combination-product programs.
- Develop and evaluate product concepts, prototypes, designs, and technical solutions.
- Apply expertise in mechanical and plastic-part design, injection molding, DFM, DFA, DFx, and tolerance analysis.
- Collaborate with electrical, software, systems, human factors, quality, regulatory, and manufacturing partners.
- Support the development, integration, and testing of electrical hardware and device software.
- Resolve technical challenges and design tradeoffs using engineering judgment and data analysis.
- Plan, execute, analyze, and document feasibility studies and prototype evaluations.
- Apply knowledge of design controls, ISO 14971, ISO 13485, DHF documentation, and design verification and validation.
- Assess how technical decisions and design changes may affect product requirements and regulatory submissions.
- Lead cross-functional technical discussions and influence decisions without direct authority.