Medical Device - Catheter Process Engineer - Hudson, MA

This Process Engineer will develop and refine catheter manufacturing and assembly processes, supporting the full product lifecycle from R&D transfer through large-scale production. The role requires strong analytical skills, technical expertise in catheter manufacturing techniques, and the ability to solve complex engineering challenges while collaborating with cross-functional teams.

Client Details

My client is an innovative medical device company focused on advancing catheter-based therapies for cardiac care. With a track record of developing novel technologies and bringing new products to market, the organization provides engineers with the opportunity to work on meaningful projects that directly impact patient outcomes.

Description

Responsibilities:

• Develop, validate, and scale catheter manufacturing and assembly processes.
• Support design transfer from R&D to manufacturing.
• Create and execute test methods, protocols, validations, and reports.
• Design fixtures, components, and subsystems for complex catheters.
• Conduct statistical analysis of process and product data.
• Build prototypes, manage DOE studies, and optimize designs for manufacturability.
• Collaborate with vendors to source materials, components, and subassemblies.

Profile

Ideal Candidate:

• Bachelor's degree in Mechanical, Biomedical, or related engineering discipline (Master's preferred).
• 3+ years of experience in catheter/disposable medical device development and commercialization.
• 2+ years developing catheter assembly processes.
• Knowledge of materials such as Pebax, nylon, PTFE, FEP, PEEK, and metals like nitinol and steel.
• Skilled in SolidWorks 3D CAD and familiar with shop/fabrication tools.
• Strong communication skills and working knowledge of medical device regulatory requirements.

Job Offer

What's To Offer:

• Direct involvement in developing life-saving cardiac technologies.
• Collaborative environment with cross-functional exposure (R&D, Quality, Clinical, Manufacturing).
• Opportunities for innovation and hands-on engineering across the full development cycle.
• Competitive compensation with growth potential based on experience and contributions.

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.