R&D Engineer- Medical Device- Hudson, MA

The R&D Engineer will play a crucial role in designing and advancing catheter technology for major healthcare and medical device companies nationwide.

Client Details

The healthcare technology company has a presence in more than 20 locations across the country and is expanding rapidly through targeted acquisitions. Its Massachusetts site houses a growing team of engineers focused on scaling operations, broadening their range of innovative medical solutions, and forging strong collaborations with healthcare providers nationwide.

Description

The R&D Engineer will be responsible for:

• Lead product design and development of catheter-based medical devices from concept to commercialization.
• Develop and optimize manufacturing processes such as extrusion, braiding, reflow, and tip-forming for catheter production.
• Ensure compliance with medical device regulations (ISO 13485, FDA 21 CFR Part 820, MDR) and maintain proper documentation.
• Conduct design verification and validation (V&V) testing, including mechanical, thermal, and biocompatibility evaluations.
• Collaborate with cross-functional teams and customers to ensure manufacturability, scalability, and product performance.
• Identify and implement process improvements to enhance efficiency, reduce costs, and improve product quality.
• Stay updated on emerging catheter technologies and drive innovation in design, materials, and performance.

Profile

The successful R&D Engineer will have what follows:

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 5+ years of experience in medical device product development, with a strong focus on catheter design and manufacturing.
• Expertise in catheter fabrication processes such as extrusion, braiding, reflow, bonding, and tip-forming.
• Proficiency in CAD software (e.g., SolidWorks) for designing and developing catheter components.
• Strong knowledge of materials (e.g., thermoplastics, silicones, braided reinforcements) used in catheter manufacturing.
• Experience with design verification and validation (V&V), including mechanical, thermal, and biocompatibility testing.
• Understanding of regulatory requirements (ISO 13485, FDA 21 CFR Part 820, MDR) and design control processes.

Job Offer

The R&D Engineer will be offered:

• Competitive base salary
• Nationally backed
• Full benefits package
• Great PTO
• Reports directly to the Senior Director of R&D

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.