Senior Process Development Engineer

Location: Hayward, CA About the Role We are partnering with an innovative medical device company to find a Sr. Process Development Engineer, Catheter Engineering. In this role, you'll help transition next-generation catheter-based devices from early-stage development into commercial manufacturing by developing robust, scalable production processes, supporting design transfer activities, and driving process improvements in a regulated medical device environment. Key Responsibilities Lead process development activities to transition catheter devices from prototype and first-in-human stages into commercial manufacturing. Develop and optimize catheter manufacturing processes, including extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser cutting. Perform DFM/DFA assessments, tolerance stack-up analyses, and establish component specifications and inspection criteria. Support process validation activities (IQ/OQ/PQ), process FMEAs, risk assessments, and manufacturing readiness efforts. Develop electrical assembly processes for catheter-integrated components, including wire terminations, cable assemblies, and surface mount components. Collaborate with Manufacturing, Quality, Regulatory, R&D, suppliers, and contract manufacturers to improve processes and ensure compliance. Establish SPC methods, capability studies (Cp/Cpk), inspection methods, and process monitoring systems to support production stability. Create manufacturing work instructions, assembly procedures, and support engineering change orders (ECOs). Apply lean manufacturing principles and lead continuous improvement initiatives to improve efficiency and reduce waste. Qualifications & Requirements Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Materials Science, or a related field. Minimum 5 years of medical device process development or manufacturing engineering experience, including at least 3 years working with catheter-based devices. Hands-on experience with catheter manufacturing processes such as extrusion, braiding, thermal bonding, adhesive assembly, tip forming, and laser processing. Proficiency with CAD software, preferably SolidWorks. This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future. #J-18808-Ljbffr