Job Description
Join MedTech Innovations as a Senior Medical Device Engineer and revolutionize patient care through cutting-edge technology. We're seeking a visionary engineer to design, develop, and validate next-generation medical devices that transform healthcare delivery. You'll collaborate with multidisciplinary teams to bring innovative solutions from concept to market, ensuring compliance with FDA regulations and ISO standards. Our state-of-the-art R&D center in Boston offers unparalleled resources for prototyping and testing. Enjoy competitive benefits, professional development opportunities, and the chance to make a tangible impact on global health outcomes.
Responsibilities
- Lead end-to-end medical device development lifecycle from ideation to FDA submission
- Design and validate hardware/software solutions for diagnostic and therapeutic applications
- Conduct rigorous risk analysis and ensure compliance with 21 CFR Part 820 and ISO 13485
- Mentor junior engineers and cross-functional teams on technical standards
- Collaborate with clinical partners to translate user needs into technical specifications
- Perform failure mode analysis and design validation testing
- Stay current on regulatory landscape and emerging healthcare technologies
Qualifications
- Bachelor's degree in Biomedical/Mechanical/Electrical Engineering (Master's preferred)
- 5+ years of experience in medical device product development
- Proven track record with FDA-regulated product submissions (510k/PMA)
- Expertise in ISO 13485 and risk management (ISO 14971)
- Proficiency in CAD software (SolidWorks/CATIA) and simulation tools
- Experience with human factors engineering and usability testing
- Demonstrated success in leading cross-functional technical projects
- Strong problem-solving skills with attention to detail