Senior Manufacturing Process Engineer
13 hours ago
Meet Our Team: Senior Manufacturing Process Engineer
A leading medical device company in San Diego county is seeking a Senior Manufacturing Process Engineer to join their process development and manufacturing engineering department. The company is pioneering breakthrough technology and innovative devices to treat cardiovascular diseases. The Manufacturing department is expanding to prepare for the upcoming launch and commercialization of new device products in the US and Europe.
Key Responsibilities:
- Develop and implement new manufacturing processes for medical devices, ensuring quality and efficiency.
- Collaborate with global suppliers to understand and define their manufacturing processes, equipment, and tools/fixtures.
- Conduct characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing.
- Create and maintain manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
- Lead a team of engineers and technicians on business activities for manufacturing, driving innovation and process improvements.
Requirements:
- Bachelor's Degree in Engineering (Mechanical, Electrical, or similar)
- Minimum of 4 years experience as a process/manufacturing engineer in the medical device industry, 5-10 years of experience preferred.
- Previous experience in catheter process development and manufacturing is required.
- Experience in Design for Manufacturing, Assembly, and Test (DFMAT), Six Sigma, Lean Manufacturing & Design of Experiments (DoE).
- Experience creating technical manufacturing documentation.
- Understanding of medical device Quality Management Systems, design controls, and product development processes.
- SolidWorks/CAD software experience.
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