Exciting opportunity to join a growing medical device company in Irvine as a Sr. Process Engineer.
In this hands on role you will bring your ideas to help develop and implement manufacturing documentation and processes for commercial non-clinical and clinical products. Will implement process controls to demonstrate process capability and continuous improvement.
- BS/MS Mechanical/Electrical/Engineering
- 5+ years medical device
- Experience with medical device product development through commercialization effort
- Understanding of ISO/FDA Quality System Requirements and guidelines and cGMPs
- Clean room experience required
- Ability to plan and schedule multiple projects and tasks
- Fishbowl software experience is a plus
- General knowledge of lab safety, MS Office and reading specification drawings
- Valuable skills include general electronic soldering/assembly, fabrication , adhesives, heat sealing and often microscopic assembly.
- Excellent interpersonal and communication skills and ability to work with people at all levels of the organization.