Process Engineer- Catheter - Medical Device

Job Description

Catheter Process Engineer - Med Device

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our client is a privately held medical device company specializing in innovative catheter-based technologies for cardiovascular care. Their mission is to advance life-saving treatments by developing the next generation of minimally invasive solutions, while ensuring scalability and patient accessibility. With a strong platform for growth and a purposeful focus on patient outcomes, the company offers employees the opportunity to directly impact the commercialization of novel devices.

We’re seeking a hands-on, detail-driven Catheter Process Engineer to join their collaborative R&D and manufacturing team. This role is central to developing robust catheter designs for manufacturability, driving new products through commercialization, and improving existing product designs and processes. It offers a unique blend of design engineering, process development, and cross-functional collaboration—ideal for someone who thrives on solving complex technical challenges while bringing innovative technologies to market.

DUTIES / EXPECTATIONS OF THIS ROLE

· Develop and optimize catheter manufacturing/assembly processes

· Design, build, and validate jigs, fixtures, and tooling for assembly processes

· Transfer design and assembly processes from R&D to Manufacturing

· Apply design for manufacture (DFM) and scalability principles

· Design and perform process validations

· Design and develop components and sub-systems for complex cardiac catheters

· Conduct design of experiments (DOE)

· Author and execute test methods, protocols, and reports

· Provide statistical analysis of data using standard industry techniques

· Produce 3D models and technical drawings

· Assemble/build prototypes and fixtures

· Execute test methods and protocols

· Collaborate with vendors to obtain components, sub-assemblies, and services in support of catheter development

MUST HAVES - QUALIFICATION SUMMARY

• BS degree or equivalent in Engineering or Science (Mechanical or Biomedical Engineering preferred)
• 3+ years of experience in development and commercialization of catheter/disposable devices
• 2+ years developing processes for catheter assembly
• Experience developing complex endoscopic, vascular, or cardiac catheter systems
• Strong knowledge of catheter manufacturing techniques/processes (UV bonding, solvent bonding, reflow, extrusion, injection molding, machining, additive manufacturing, swaging, tipping)
• Reflow of plastics, welding processes on fine wires and exotic metals
• Knowledge of catheter materials (Pebax, nylon, PTFE, FEP, PEEK, nitinol, steel)
• 3D CAD modeling (SolidWorks)
• Good written and verbal communication skills
• Working knowledge of regulatory requirements for medical devices
• Understanding of statistics for design applications and process controls (distribution types, tests of means/variance, Ppk, Cpk)
• Demonstrated ability to take projects from concept through product realization
• Shop/fabrication skills (hand tools, drill press, bandsaw, lathe/mill familiarity a plus)

NICE TO HAVE

· MS degree in Mechanical or Biomedical Engineering

· Familiarity with lathe and mill operations

· Exposure to development of radio frequency ablation systems or electroporation systems

· Prior consulting or cross-functional project leadership experience

TRAVEL & LOCATION

On site greater Boston area

START & TERM

ASAP. Full time Employment