Eliassen Group
Overview
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
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 Qualifications
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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Industries Medical Equipment Manufacturing
#J-18808-Ljbffr
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
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 Qualifications
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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Industries Medical Equipment Manufacturing
#J-18808-Ljbffr