Senior R&D Engineer - Medical Devices

About the Company

Fast-growing medical device startup based in Canton, MA developing an innovative Class III implantable endoscopic GI system. The company has successfully completed clinical trials with outstanding results and recently received FDA approval on the flagship application, and is working on improvements to the device, & also next-gen applications for the technology

This role will focus on development of the company’s next-generation implantable access device
, supporting future product expansion beyond the flagship system.

• Mechanical design and development of next-generation implantable components
• Hands-on work with nitinol
  , silicone
  , and other implantable materials
• Design for Injection-Molded components
• Design and development of catheter-based and minimally invasive components
• Prototyping, benchtop testing, and iterative design refinement
• Collaboration with Quality and Regulatory teams to ensure designs meet safety, performance, and compliance requirements

This role will focus on design optimization and manufacturing scalability of the FDA-approved flagship system in preparation for U.S. commercial launch.

• Develop and maintain detailed CAD models, drawings, and specifications
• Build and test prototypes to validate mechanical performance and usability
• Develop and execute bench testing protocols and document results
• Author and maintain engineering documentation in compliance with FDA and ISO 13485 requirements
• Collaborate cross-functionally with Manufacturing, Quality, Regulatory, and Clinical teams as needed to support commercialization

• Bachelor’s or Master’s degree in Mechanical Engineering or related discipline
• 4-8+ years of relevant experience (level dependent)
• Strong understanding of mechanical design principles and tolerance analysis
• Proficiency with 3D CAD software (e.g., Solid Works, Creo)
• Experience working in a regulated medical device environment
• Comfortable working in a fast-paced startup environment

• Experience with Class III implantable devices
• Hands-on experience with nitinol and/or polymer components
• Experience supporting products transitioning from development to commercial launch

• Base salary range: $100K – $150K
  , commensurate with experience and level
• Annual performance bonus
• Stock options / equity participation
• Full medical, dental, and vision benefits
• 401(k) plan
• Paid time off and company holidays

• Be part of a team bringing a successfully clinically validated, FDA-approved Class III device to U.S. market
• Direct impact on product quality, manufacturability, and patient outcomes
• High ownership and visibility in a growing, mission-driven startup
• Opportunity to work on both commercial launch and next-generation innovation

• Local Candidates strongly preferred
• No H1B or Visa Sponsor ships - must have US Work Authorization or be a US Citizen