Senior Research And Development Engineer

Suru; Marlborough (MA); On-site; USD 130,000 - 190,000; Full time

Job summary

Suru is seeking a Senior R&D Engineer to drive design and development of next-generation catheter-based medical devices from concept to design transfer. The role blends hands-on prototyping with rigorous documentation and adherence to design controls in a fast-paced lab environment.

You will mentor engineers, lead cross-functional teams across Manufacturing, Process Development, Quality, Regulatory, and Program Management, and ensure robust engineering reports, protocols, and test data to

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 7-15+ years of Medical Device R&D or Product Development experience.
• Experience with catheter manufacturing processes including extrusion, thermal bonding, reflow, braiding, coil reinforcement, or catheter assembly.
• Strong background working within structured medical device product development environments.
• Extensive experience creating engineering drawings, design documentation, specifications, protocols, and technical reports.
• Strong understanding of medical device design controls and product development processes.
• Experience performing prototype development, bench testing, troubleshooting, and design iteration.
• Excellent technical writing, communication, and cross-functional collaboration skills.

Responsibilities

• Lead the design and development of catheter-based medical devices from concept through design transfer.
• Build, assemble, and evaluate catheter prototypes while supporting feasibility and proof-of-concept activities.
• Develop fixtures, tooling, and sub-assemblies to support product development and engineering testing.
• Perform bench testing, analyze engineering data, and drive iterative design improvements.
• Create high-quality engineering documentation including drawings, specifications, design history documentation, engineering reports, protocols, and technical documentation.
• Support design controls, risk management activities, verification planning, and design transfer.
• Collaborate closely with Manufacturing, Process Development, Quality, Regulatory, and Program Management throughout the product development lifecycle.
• Mentor junior engineers and provide technical guidance during development activities.
• Balance hands-on laboratory work with technical documentation and cross-functional project leadership.

Skills

Technical writing

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related technical discipline

Job description

Our client is seeking a Senior R&D Engineer to support the design and development of next-generation catheter-based medical devices. This individual will play a key role in driving product development from concept through design transfer, combining hands-on engineering with the technical rigor required to support product documentation, design controls, and cross-functional development activities.

This is a highly visible role for an experienced medical device engineer who has developed catheter-based products within a structured product development environment but still enjoys working in the lab. The ideal candidate is equally comfortable building and testing prototypes, creating high-quality engineering documentation, and leading technical efforts across multiple projects. They are looking for someone who brings the discipline and best practices of a larger medical device organization while maintaining the adaptability and urgency of a startup environment.

Day-to-Day

• Lead the design and development of catheter-based medical devices from concept through design transfer.
• Build, assemble, and evaluate catheter prototypes while supporting feasibility and proof-of-concept activities.
• Develop fixtures, tooling, and sub-assemblies to support product development and engineering testing.
• Perform bench testing, analyze engineering data, and drive iterative design improvements.
• Create high-quality engineering documentation including drawings, specifications, design history documentation, engineering reports, protocols, and technical documentation.
• Support design controls, risk management activities, verification planning, and design transfer.
• Collaborate closely with Manufacturing, Process Development, Quality, Regulatory, and Program Management throughout the product development lifecycle.
• Mentor junior engineers and provide technical guidance during development activities.
• Balance hands-on laboratory work with technical documentation and cross-functional project leadership.

Requirements / Qualifications

Must Haves

• Bachelor's degree in Engineering or a related technical discipline.
• 7-15+ years of Medical Device R&D or Product Development experience.
• Experience with catheter manufacturing processes including extrusion, thermal bonding, reflow, braiding, coil reinforcement, or catheter assembly.
• Strong background working within structured medical device product development environments.
• Extensive experience creating engineering drawings, design documentation, specifications, protocols, and technical reports.
• Strong understanding of medical device design controls and product development processes.
• Experience performing prototype development, bench testing, troubleshooting, and design iteration.
• Excellent technical writing, communication, and cross-functional collaboration skills.

Nice to Have

• Experience supporting new product introductions (NPI).
• Experience with DFMEA, pFMEA, and risk management.
• Experience mentoring junior engineers.
• Startup or fast-paced product development experience.