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 devices2+ years developing processes for catheter assemblyExperience developing complex endoscopic, vascular, or cardiac catheter systemsStrong 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 metalsKnowledge of catheter materials (Pebax, nylon, PTFE, FEP, PEEK, nitinol, steel)3D CAD modeling (SolidWorks)Good written and verbal communication skillsWorking knowledge of regulatory requirements for medical devicesUnderstanding 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 realizationShop / fabrication skills (hand tools, drill press, bandsaw, lathe / mill familiarity a plus)NICE TO HAVE
MS degree in Mechanical or Biomedical EngineeringFamiliarity with lathe and mill operationsExposure to development of radio frequency ablation systems or electroporation systemsPrior consulting or cross-functional project leadership experienceTRAVEL & LOCATION
On site greater Boston area
START & TERM
ASAP. Full time Employment