Senior Process Development Engineer

Job Description Summary Overview:

Mentor staff and consult on bio-material processing in the R&D Engineering Group. Identify, develop, and implement new processes to support product development. Coordinate new process development efforts including documentation and release to production, (design transfer). Work with product development teams to insure manufacturability of new products.

Responsibilities:

Develop new process designs for products developed by the R&D Group
Develop process capability metrics and methodology to demonstrate and control those metrics
Assist in new product transfer by preparing and releasing qualification documents from R&D to facilitate seamless transfer to operations.
Research leading edge technology regarding tissue processing and packaging to advance mfg.

Requirements:

B.Sc. required, M.Sc. preferred, Chemical Engineering, Material Science, or Industrial Engineering (Operations Research)

5 - 10 years process engineering experience developing medical devices. Excellent written and verbal communication skills required.

Knowledge of DFSS, DOE and process capability methodology required.

Six Sigma Black Belt preferred.

GMP’s and FDA requirements are a definite plus.

Ideal candidate will have capital equipment acquisition experience along with a history of conducting related qualification work. Experience working in a cleanroom environment preferred along with exposure to optimized production layout.

Computer Skills:

MS Word, Excel, Project, Solid Works, AutoCAD.

Outstanding work environment with time spent in controlled environment cleanrooms and labs. Will work on development teams where progressive ideas and recommendations are encouraged.

Training Requirements:

R&D product development SPs, ECO, Deviation, NPR Documentation Procedures, Design Control Procedures, Clean Room Gowning Procedure, QAD Bills and Routers

Job Status: Full Time, Ability to travel, including occasional overnight trips

Compensation: DOE

Job Location: St. Paul, MN 55114

Contact Information:

Lori Chmiel
Senior Executive Recruiter
952-847-3287
Lori.chmiel@engageitresources.com