R&D Principal Engineer to lead end-to-end development of advanced medical devices for pain management and chronic care, improving patient outcomes.
Key Responsibilities
- Own product development from concept through verification, validation, and design transfer.
- Ensure compliance with FDA, ISO, and IEC requirements.
- Translate clinical needs into system and product requirements.
- Guide system architecture and technical design decisions.
- Oversee risk management activities to support patient safety and reliability.
- Lead and contribute to design reviews; drive innovation and robustness of designs.
- Collaborate cross-functionally with clinical, quality, regulatory, and manufacturing teams.
- Mentor engineers and champion best practices across global programs.
Required Qualifications & Skills
- Proven leadership in medical device R&D and product lifecycle development.
- Strong knowledge of regulatory and quality standards (FDA/ISO/IEC).
- Expertise in requirements development, verification/validation, and design transfer.
- Competence in risk management and design review processes.
- Ability to design system architecture and communicate effectively across disciplines.