Manufacturing Engineer

The Mechanical Manufacturing Engineer will focus on new or improved products, fixtures, equipment, or processes with significant impact in the scale up and cost down of the manufacturing process.
-Provide input on the manufacturability of new products
-Design and develop tooling, equipment, functional drawings and fixtures for new and existing products
-Design and develop new methods and processes for the manufacture of new and existing products
-Identify, design or purchase, and implement manufacturing aids (fixtures, jigs, tools, etc.) to reduce manufacturing costs associated with direct labor, scrap and rework.
-Perform DOE-type engineering and optimization studies
-Perform Process Validation tasks related to new products & processes (equipment qualification, PQ, -Identify product design changes to improve quality and reduce cost
-Evaluate processes to identify areas to improve quality, cost efficiency and employee safety
-Author test protocols, reports & manufacturing documents related to new processes
-Troubleshoot product returns for root cause, identify possible solutions, and test
-Key contributor in the design and roll out of new product introduction into hi-volume production
-Knowledge of FDA regulated medical device product manufacturing process; experience with introduction of new products, and development of new manufacturing processes.
-Thorough understanding of FDA, GSR, and cGMP requirements

Primary Skills: 5+ years in production/manufacturing management of medical device products ideally with both, start up and large company experience

Other Details: Expertise in tool, component and fixture design
-History of successfully optimizing manufacturing processes
-Experience with mechanical assembly is required, catheter experience is required, electro -mechanical is desired
-Experience with adhesives and injection molding is required

Proficiency in SolidWorks

History of success in being able to conceptualize, design, assemble and debug tooling and fixtures to optimize existing and new manufacturing processes

Strong documentation skills, familiar with FDA requirements

If you are interested in this position in Beautiful Southern California, and have the expertise that is required, please submit your resume ASAP for consideration.

KEYWORDS: Medical device, iso 13485, QSR, iso 14971, injection molding, manufacturing, mechanical engineering, MSME,BSME, GMP,cGMP, equipment validations, process validations, troubleshoot, fixtures, toolingTo find out more about Real Staffing please visit www.realstaffing.com