Job Description
Join MedTech Innovations as a Senior Medical Device Engineer and pioneer the next generation of life-saving healthcare technology. We're seeking a visionary engineer to lead the development of cutting-edge surgical robotics systems in our state-of-the-art Boston R&D center. Collaborate with cross-functional teams to transform innovative concepts into FDA-approved devices that directly impact patient outcomes. Enjoy competitive compensation, comprehensive benefits, and the opportunity to shape the future of minimally invasive procedures.
Responsibilities
- Lead end-to-end development of surgical robot systems from prototype to clinical validation
- Design and validate electromechanical components with ISO 13485 compliance
- Conduct rigorous risk analysis and failure mode testing per IEC 62304 standards
- Mentor junior engineers and manage project timelines using Agile methodologies
- Collaborate with clinical partners to incorporate real-world surgical requirements
- Prepare technical documentation for FDA submissions and regulatory approvals
- Research emerging materials and actuation technologies for next-gen devices
Qualifications
- MS in Biomedical/Mechanical Engineering with 5+ years medical device experience
- Proven track record in surgical robotics or implantable device development
- Expertise in CAD (SolidWorks) and FEA simulation (ANSYS)
- Familiarity with FDA QSR, ISO 13485, and risk management processes
- Strong programming skills (Python/C++) for embedded systems control
- Experience with rapid prototyping and 3D manufacturing techniques
- Certification in Six Sigma or PMP preferred
- Excellent communication skills for cross-functional collaboration