Senior Manufacturing Engineer

The Sr. 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, PPQ)
-Selection of equipment to support manufacturing processes, including scale up of new and prototype processes
-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
-Interface daily with in-house and contract manufacturing engineering teams to identify/resolve problems and implement solutions to stabilize product.
-Key contributor in the design and roll out of new product introduction into hi-volume production
-Apply and reinforce Design for Manufacturing (DFM) strategies to address ease of manufacturing, cost and quality goals
-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
To find out more about Real please visit www.realstaffing.com