Job Description
Join our pioneering team at MedTech Innovations, where we're revolutionizing patient care through cutting-edge medical devices. As a Senior Medical Device Engineer, you'll lead the design, validation, and regulatory compliance of next-generation diagnostic equipment. Collaborate with cross-functional teams to transform innovative concepts into life-saving solutions. Enjoy competitive compensation, comprehensive benefits, and the opportunity to work in a state-of-the-art R&D facility at the heart of Boston's thriving biotech corridor.
Responsibilities
- Lead end-to-end development of Class II/III medical devices from prototype to production
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other regulatory standards
- Design and validate mechanical/electrical systems for diagnostic equipment
- Conduct risk analysis and mitigation using FMEA and hazard analysis methodologies
- Mentor junior engineers and drive continuous improvement processes
- Collaborate with clinical teams to translate user requirements into technical specifications
- Manage product lifecycle documentation including DHRs, DHFs, and risk files
Qualifications
- Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering (Master's preferred)
- 5+ years of experience in medical device development with 2+ years in leadership roles
- Proven expertise with FDA submissions and design control processes
- Strong proficiency in CAD (SolidWorks) and simulation tools
- Experience with ISO 13485 and FDA QSR compliance frameworks
- Demonstrated success in bringing medical devices from concept to market
- Excellent problem-solving skills and ability to work in regulated environments
- Strong project management skills with experience in Agile methodologies