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Engineer II

Orange County Metro Area, CA

Posted: 09/03/2019 Job Type: Engineering Job Number: JN -092019-25545

Engineer II

Irvine, CA

New Medical Device Regulations (MDR) requires us to review and update documentation and standards for our products. This position will assist our R&D team in this update activity.


Duties:


Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports (45%)

Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk (20%)

Develop, update, and maintain technical content of risk management files (15%)

Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes (10%)

Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work (5%)


Skills:


Previous experience writing protocols/reports and conducting design verification testing preferred

Previous experience creating and editing design requirements documents preferred


Education:


Bachelor's Degree or equivalent in Engineering or Scientific field with 2 years related work experience

Required or Master's Degree or equivalent and internship, senior projects or thesis in Engineering or Scientific field with including either industry or industry/education Required

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