Senior Engineer - Tech Transfer
Reading Metro Area, PA
- Senior Engineer
- BS or MS in Engineering with 7-9 years of experience in an engineering role at a GMP / FDA regulated manufacturing facility.
- Experience with the creation and execution of protocols for process IQ,OQ,PQ Proficient with Microsoft Office products.
- PREFERRED EXPERIENCE10+ years experience in a medical device manufacturing facility Experience transferring new product designs from R&D to Manufacturing Proficient with ProEngineer WORK SCHEDULE 1st Shift, Monday-Friday
- Design Transfer: Transfer new product designs from R&D into a manufacturing facility.
- Develop and validate manufacturing equipment and processes for new products.
- Duties may include the following activities: Conduct design for manufacturability and assembly analysis of new product designs to support the development of efficient manufacturing processes. Conduct design for injection molding analysis for parts that are to be injection molded to support dependable component availability. Conduct design for automation analysis for forward looking consideration of automated assembly. Coordinate and execute prototype builds for R&D product verification testing. Develop assembly processes and conduct testing to demonstrate process viability. Develop or work with machine design vendors to develop assembly equipment. Create operator work instructions for assembly processes. Create and execute component qualification protocols for the manufacture of new parts by outside suppliers. Create and execute fixture and process validation protocols for the implementation of new manufacturing fixtures and processes at the manufacturing site.