Senior R&D Engineer- Medical Device- Marlborough, MA

We're seeking a Senior Product Development Engineer with deep experience in catheter design and development to lead projects from concept through commercialization. This is a unique opportunity to join a small, agile team where your contributions will directly shape product strategy and patient outcomes.

Client Details

They are a rapidly growing medical device manufacturer specializing in advanced catheter technologies for a range of interventional and diagnostic applications. Following a strategic acquisition of a complementary organization across the country, we've significantly expanded our product portfolio and established a stronger national footprint. As part of this growth, we're investing in our local R&D capabilities and building a high-impact team focused on innovation and speed-to-market. This newly created role reflects our commitment to expanding engineering leadership and driving next-generation catheter solutions.

Description

• Lead design and development of catheter-based devices, including concept generation, prototyping, and design iteration based on clinical and user needs.
• Own the product lifecycle from feasibility through design transfer, ensuring alignment with regulatory and quality standards.
• Develop and execute test protocols for design verification and validation, including mechanical, flow, and fatigue testing of catheter components and assemblies.
• Collaborate with manufacturing engineering to optimize designs for scalability, cost-effectiveness, and manufacturability, including material selection and process development (e.g., extrusion, tipping, bonding, braiding).
• Author and maintain design documentation, including design history files, risk analyses (FMEA), engineering drawings, and specifications.
• Interface with suppliers to source components, evaluate new materials, and troubleshoot manufacturing challenges.
• Support regulatory submissions by providing technical documentation and participating in audits or reviews as needed.
• Mentor junior engineers and contribute to technical reviews, design brainstorming sessions, and continuous improvement initiatives.
• Stay current on industry trends and emerging technologies in catheter design, biomaterials, and minimally invasive delivery systems.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state, or local law. MPI encourages applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.

Profile

A successful Senior R&D Engineer should have:

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related discipline.
• Minimum 4 years of hands-on experience in product development within the medical device industry, specifically involving catheter systems or minimally invasive technologies (internships not counted).
• Strong understanding of catheter design principles, including shaft construction, tip forming, bonding techniques, and material selection (e.g., Pebax, nylon, PTFE, stainless steel, nitinol).
• Experience with design controls and documentation in a regulated environment (FDA, ISO 13485), including DHF creation, risk management (ISO 14971), and design verification/validation.
• Proficiency in CAD tools, preferably SolidWorks, for designing components and assemblies, and generating manufacturing drawings.
• Working knowledge of manufacturing processes such as extrusion, laser cutting, injection molding, thermal bonding, and braiding.
• Demonstrated ability to lead cross-functional projects, manage timelines, and communicate effectively with internal and external stakeholders.
• Comfortable working in a fast-paced, iterative R&D environment, with a strong sense of ownership and accountability.
• Experience with testing and characterization of catheter performance (e.g., tensile, torque, kink resistance, flow rate, burst pressure) is highly desirable.

Job Offer

• Competitive salary ranging from $110,000 to $135,000annually.
• Comprehensive benefits package.
• Equity package depending on years of experience.
• Bonus structure.
• Collaborative and supportive work environment.
• Professional growth opportunities within the engineering and manufacturing sector.

If you're ready to take your career to the next level, we encourage you to apply today!

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.