Senior Manufacturing Engineer (Onsite)
A growing medical device company located in San Diego county is looking to hire a Senior Engineer for their process development and manufacturing engineering department. The company is developing breakthrough technology and innovative devices to treat cardiovascular diseases. The Manufacturing department is growing to prepare for the upcoming launch and commercialization of new device products in the US and Europe. This role will be responsible for the development of new and improved manufacturing processes for catheter based medical devices and manufacturing scale-up projects for existing product lines.
Role Responsibilities:
- Create and implement new manufacturing processes for new and current medical devices.
- Work with suppliers around the world to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality products are being delivered.
- Perform characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
- Create manufacturing documentation including but not limited to work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
- Lead team of engineers and technicians on business activities for manufacturing.
- Innovate, design, and develop processes, procedures, tooling and/or automation.
Qualification 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 catheter process development and manufacturing experience is required.
- Experience in Design for Manufacturing, Assembly, and Test (DFMAT), Six Sigma, Lean Manufacturing & Design of Experiments (DoE).
- Experience creating technical manufacturing documentation such as work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
- Understanding of medical device Quality Management Systems, design controls, and product development processes.
- SolidWorks/CAD software experience.
