Research And Development Engineer

This range is provided by Cambridge Recruiters. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$90,000.00/yr - $/yr

Annual Bonus and Stock options

Direct message the job poster from Cambridge Recruiters

R&D Engineer I / II – Mechanical (Two Open Positions)

Location: Canton, MA (On-site)

Company Size: ~30 employees

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

Employment Type: Full-Time, Permanent

We are a fast-growing medical device startup based in Westwood, MA, developing an innovative Class III implantable endoscopic GI system. Our team of approximately 30 employees has successfully completed clinical trials with outstanding results and received FDA approval
.

We are now entering a pivotal phase focused on manufacturing readiness, product refinement, and next-generation development
, with plans to commercially launch our flagship system in the U.S. market in 2026
.

We are hiring two R&D Engineers (Level I or II) with strong mechanical engineering fundamentals to support both next-generation device development and design-for-manufacturability improvements to our FDA-approved product platform.

Both roles are full-time, permanent positions offering competitive compensation, full benefits, annual bonus, and equity participation. Final leveling (Engineer I or II) will be based on experience.

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 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.

• Design‑for‑manufacturability and design‑for‑assembly (DFM/DFA) improvements
• Optimization of handle, shaft, and catheter subassemblies for ease of assembly and production yield
• Close collaboration with injection molding vendors to refine part geometry, tolerances, materials, and tooling
• Support manufacturing scale‑up, cost reduction, and reliability improvements
• Implementation of design changes within an established design control framework

• 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 degree in Mechanical Engineering or related field
• 1–6+ years of relevant experience (level dependent)
• Experience with catheters, endoscopic systems, or minimally invasive medical devices
• 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 silicone components
• Experience working with injection molding vendors and tooling development
• Familiarity with catheter shaft and handle construction, bonding, and assembly processes
• Experience supporting products transitioning from development to commercial launch
• Base salary range: $90,000 – $120,000 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 current US Work Authorization or be a US Citizen

• Mid‑Senior level

• Full‑time

• Medical Equipment Manufacturing