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Sr. Engineer

Orange County Metro Area, CA

Posted: 10/18/2019 Job Type: Engineering Job Number: JN -102019-25843

Job Description

Sr. Engineer

Lifesciences Industry

Irvine, CA


1. Investigate 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%)

2. Identify and ensure the optimization of complex Manufacturing and/or R&D 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%)

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

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

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

6. Train, coach, and guide lower level employees on routine procedures. (5%)

Possibility of travel if assignment is extended- US travel

Top 3 Skills

Self-motivated and high sense of urgency. See process through to completion

Communication and solution based/ resourceful

Needs to have good understanding of process development and should be very hands-on


Medical Device Experience Required

3-5 years of engineering experience

Bachelor's Degree in Engineering or related field

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