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Catheter Process Engineer - Med Device

Catheter Process Engineer - Med Device

Eliassen GroupMarlborough, MA, US
3 days ago
Job type
  • Full-time
Job description

Job Description

Client 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 in Marlborough, MA

    START & TERM

    ASAP. Full time Employment

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    Device Engineer • Marlborough, MA, US

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