Job Description
Join our pioneering team at MedTech Innovations, where we transform healthcare through cutting-edge medical device solutions. We seek a Senior Medical Device Engineer to lead the design, development, and validation of next-generation diagnostic and therapeutic devices. Collaborate with cross-functional teams to ensure regulatory compliance (FDA/ISO 13485) while driving innovation in patient care. Enjoy competitive benefits, flexible work arrangements, and opportunities to impact global healthcare outcomes.
Responsibilities
- Lead end-to-end product development lifecycle from concept to commercialization
- Design and validate medical devices adhering to FDA 21 CFR Part 820 and ISO 13485 standards
- Conduct risk analysis (FMEA/FMECA) and ensure safety-critical system reliability
- Collaborate with R&D, regulatory, and clinical teams for seamless integration
- Develop test protocols and perform verification/validation activities
- Stay current on evolving medical device regulations and industry best practices
Qualifications
- Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering (Master's preferred)
- 5+ years of medical device development experience with FDA-regulated products
- Proficiency in CAD (SolidWorks/CATIA) and simulation tools (ANSYS/COMSOL)
- Demonstrated knowledge of ISO 13485 and FDA QSR requirements
- Experience with risk management per IEC 62304 standards
- Strong problem-solving skills and ability to lead complex technical projects