Description:
The Product Development Engineer I supports product development activities from concept through commercialization, executing design controls, testing, risk management, and documentation in compliance with QMSR, ISO 13485:2016, and ISO 14971.
Duties and Responsibilities:
- Support design transfer activities including DFM/DFA input, pilot builds, process development, and required documentation.
- Develop and validate test methods; design simple fixtures to enable repeatable testing.
- Maintain requirements traceability and contribute to formal design reviews.
- Execute verification protocols, analyze data, and generate compliant reports.
- Perform feasibility studies, product characterization, and risk analysis.
- Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and suppliers.
- Participate in customer meetings and present technical updates as needed.
- Maintain accurate engineering documentation throughout all development phases.
