Senior R&D Engineer - Medical Devices

Senior R&D Engineer

Location: Canton, MA (On-site)

Company Size: ~30 employees

Industry: Class III Implantable Medical Devices (GI / Catheter/Scope/Endoscopic)

Employment Type: Full-Time, Permanent

About the Company

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

Senior R&D Engineer – Nitinol Implant & Materials Development focus

Core Responsibilities

• Develop and maintain detailed CAD models, drawings, and specifications
• Material & Implant design, build and test prototypes to validate mechanical performance and usability
• Develop and execute bench testing protocols and document results
• Support risk management activities (e.g., design FMEAs)
• 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

Required Qualifications

• Bachelor’s or Master's degree in Mechanical Engineering or related discipline
• 4-8 years' experience with Medical Devices
• Strong understanding of mechanical design principles and tolerance analysis
• Proficiency with 3D CAD software (e.g., SolidWorks, Creo)
• Experience working in a regulated medical device environment
• Comfortable working in a fast-paced startup environment
• Excellent communication skills

Preferred Qualifications

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

Compensation & Benefits (both roles)

• Base salary range: $130K – $160K, commensurate with experience
• Annual performance bonus
• Stock options / equity participation
• Full medical, dental, and vision benefits
• 401(k) plan
• Paid time off and company holidays

Why This Opportunity:

• 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

Additional Notes

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