Attractive R&D/Manufacturing Engineering opportunity with an established and growing cardiac device company developing a new line of advanced catheters that deliver the latest ablation therapies. Key role reporting to the Director of R&D, with a focus on developing robust designs and processes for commercialization.
The successful candidate in the position will develop new catheters and improve the design and manufacturing processes of current products. The scope includes product and process development, invention, evaluation of manufacturing techniques, device and fixture design, and creation of procedures and technical documents. This role requires strong analytical and problem-solving skills and detailed knowledge of catheter manufacturing techniques. The candidate will collaborate with a cross-functional team of engineers and technicians.
Responsibilities
- Design for Manufacture and scalability of components and subsystems for complex cardiac catheters.
- Produce 3D models and technical drawings.
- Develop, optimize, transfer manufacturing and assembly processes from R&D toManufacturing and perform process validations.
- Perform Design of Experiments, write and execute test methods, protocols, and reports.
- Provide statistical analysis of data.
- Assemble and build prototypes and fixtures.
- Work with vendors of catheter components, sub-assemblies, and services.
Qualifications
- BS or MS in Mechanical, Manufacturing, Plastics, or Biomedical Engineering.
- Three – ten years of successful experience in product and process development of complex catheter systems for endoscopic, vascular, cardiac or similar applications.
- Strong knowledge of catheter fabrication and manufacturing techniques and processes, such as UV and Solvent Bonding, Reflow, Extrusion, Injection Molding, Machining, Additive Manufacturing, Swaging, and Tipping..
- Knowledge or experience processing typical polymer and metal catheter materials, e.g. Pebax, nylon, PTFE, FEP, PEEK, Nitinol, Steel.
- Experience developing endoscopic, vascular or cardiac catheter systems is a plus.
- Competence using SolidWorks for modeling, shop and fabrication hand tools, drill presses, bandsaws; familiarity with lathes and milling is a plus.
- Understanding and use of statistics for design applications and process controls.
- Ability to write clear reports, specifications, and proposals, and effectively discuss them with a multi-disciplinary team that included R&D, Manufacturing, Quality, Clinical, and Marketing.
- Working knowledge of regulatory requirements for medical devices.