Manufacturing Engineer

Manufacturing Engineer (Onsite)

A growing medical device company located in San Diego county is looking to hire a hands-on Manufacturing Engineer for their process development and manufacturing department. The company is developing breakthrough technology and innovative electrophysiology devices to treat cardiovascular diseases. The Manufacturing team 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 process improvement projects and manufacturing line support for catheter devices and disposable products.

Role Responsibilities:

• Improve 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, Biomedical, or similar)
• 2-5 years experience as a process/manufacturing engineer in the medical device industry.
• Previous catheter and disposable device manufacturing experience is required.
• Hands-on fixture design experience.
• Prior experience working at a fast-paced start up company.
• 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.