What are the responsibilities and job description for the Research And Development Engineer position at 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
About the Company
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.
Position Overview
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.
Position 1: R&D Engineer – Next-Generation Device Development
This role will focus on development of the company’s next-generation implantable access device, supporting future product expansion beyond the flagship system.
Key Focus Areas
- 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
Position 2: R&D Engineer – Existing Product Design Improvements
This role will focus on design optimization and manufacturing scalability of the FDA-approved flagship system in preparation for U.S. commercial launch.
Key Focus Areas
- 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
Core Responsibilities (Both Roles)
- 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
- 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 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., 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 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
Compensation & Benefits
- 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
Why Join Us
- 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 current US Work Authorization or be a US Citizen
Salary : $90,000 - $120,000