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

Full TimeOn Site
Hudson, Massachusetts

, Hudson, Massachusetts 01749 • Michael Page - Hudson, Massachusetts

Senior R&D Engineer

Join a rapidly growing medical device organization focused on developing innovative catheter-based technologies that are advancing cardiovascular care. This is a highly visible role within an established R&D team where you will play a critical part in designing, developing, and commercializing next-generation catheter products from concept through production.

Lead the design and development of catheter components and subsystems

Drive new product development activities from concept through commercialization

Create and maintain engineering documentation including drawings, protocols, reports, and procedures

Develop, evaluate, and optimize manufacturing processes

Design and execute test methods, verification protocols, and design of experiments (DOE)

Perform data analysis and provide statistical evaluations to support product development decisions

Build prototypes, fixtures, and assemblies for development testing

Collaborate cross-functionally with Manufacturing, Quality, Clinical, and Regulatory teams

Partner with external suppliers and vendors to support development efforts

Support transfer of products and processes from R&D into manufacturing environments

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.

A successful Senior R&D Engineer should have:

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline

5+ years of medical device product development experience

3+ years of catheter development experience

Proven success bringing products from concept through commercialization

Strong understanding of catheter manufacturing processes including UV bonding, solvent bonding, extrusion, reflow, injection molding, swaging, tipping, machining, or additive manufacturing

Experience working with catheter materials such as Pebax, PTFE, FEP, PEEK, Nylon, Nitinol, and stainless steel

Proficiency with SolidWorks and 3D CAD design

Experience with statistical analysis and design verification activities

Strong technical communication and documentation skills

Working knowledge of medical device quality systems and regulatory requirements

Direct impact on the development of innovative cardiovascular medical technologies

High level of technical ownership and visibility

Collaborative engineering environment with experienced industry professionals

Opportunity to contribute to products that improve patient outcomes

Stable, growth-oriented medical device organization with an active development pipeline