The Product Development Engineer is a self-starter who will play a key role in developing robust catheter designs for manufacturability, bring new products to commercialization, and improve design and processes of current products. Responsibilities include developing and evaluating manufacturing processes, solving unique technical challenges, ideation and invention, device and fixture design, authoring procedure and technical documents. This role requires strong analytical and problem-solving skills and detailed knowledge of catheter manufacturing techniques. The candidate will need to effectively collaborate with a cross-functional team including engineers and technicians in achieving objectives.

Essential Duties and Responsibilities include the following:

• Develop and optimize catheter manufacturing/assembly processes

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

• Design for manufacture (DFM) and scalability

• Design and perform process validations

• Design and develop components and sub-systems for a complex cardiac catheter

• 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

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

Core Competencies/Skill and Abilities Required:

• Experience developing complex endoscopic, vascular or cardiac catheter systems

• Strong knowledge of catheter manufacturing techniques/processes required (UV Bonding, Solvent Bonding, Reflow, Extrusion, Injection Molding, Machining, Additive Manufacturing, Swaging, Tipping)

• Knowledge of an experience in processing typical catheter materials (Polymers such as Pebax, nylon, PTFE, FEP, PEEK, materials such as Nitinol, Steel)

• 3D CAD modeling in SolidWorks

• Good written and verbal communication skills - must be able to write clear reports, specifications, proposals and effectively discuss them with other members of a multi-disciplinary team (R&D, MFG, Quality, Clinical, Marketing)

• Working knowledge of regulatory requirements for medical devices

• Understanding of statistics for design applications and process controls (data distribution types, tests of means, tests of variance, Ppk, Cpk)

• Shop/fabrication skills (familiar with use of hand tools, drill press, bandsaw required. Familiarity with lathe and mill a plus

• Exposure to the development of radio frequency ablation systems or electroporation systems is a plus.