What are the responsibilities and job description for the Senior R&D Engineer- Medical Device- Marlborough, MA position at Michael Page?
The Senior R&D Engineer will be a key player in the development and design of catheters for some of the largest medical device and health-care organizations across the country.
Client Details
The medical device organization operates over 20 locations nationwide and continues to grow through strategic acquisitions across the U.S. The Massachusetts facility has a small but expanding team of engineers, actively increasing headcount, developing a diverse product portfolio, and strengthening partnerships with healthcare organizations across the country.
Description
The Senior 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 Senior 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 Senior 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.
Salary : $100,000 - $120,000
