Senior Process Development Engineer (Automated Packaging)



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Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

Manpower Engineering has partnered with a growing medical device company that is now hiring for a Senior Process Development Engineer to join their successful team.

You will work in an entrepreneurial and collaborative environment where innovation and creative thinking are highly valued. The company is focused on empowering employees, providing flexibility with accountability and plenty of opportunity for long-term career growth.


The Senior Process Development Engineer will lead efforts to design, develop, implement, and maintain processes and equipment used to manufacture existing products and products in development. Processes include but are not limited to mid-to-high volume complex assembly, packaging, and labelling.


* Collaborate with cross-functional teams to understand user/product requirements and recommend design for manufacturability elements for the product design

* Design and develop manufacturing processes and equipment that are lean and mistake-proof

* Develop equipment specifications and work with suppliers to quote, procure, and implement

* Develop process validation plans, lead the execution of plans, and document results in reports

* Lead cross-functional teams to develop pFMEA's and other risk assessments and implement effective manufacturing controls

* Collaborate with Operations team to develop effective process work instructions

* Implement equipment calibration and maintenance plans/schedules

* Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions

* Develop and validate test methods used in manufacturing

* Lead cross-functional teams to develop and manage project plans and schedules

* Identify and implement continuous improvement projects compliant with change management procedures

* Develop cost of goods estimates and cost/benefit analyses

* Provide guidance and mentorship to other engineers and technicians

* Lead CAPA projects and problem-solving efforts


* Bachelor's degree in Engineering or related field

* Six Sigma Black Belt preferred

* 5-10 years of experience in manufacturing process development including characterization, process optimization, validation, and ramping production for high-volume specifications

* 5+ years of experience in the medical device, pharmaceutical, or other highly regulated industry

* Strong knowledge of Automated Packaging and/or related automated equipment

* Proven ability to write thorough technical protocols, plans, and reports

* Ability to provide innovative solutions to complex problems

* Excellent written and verbal communication skills

* Experience creating, writing, and executing process/equipment IQ/OQ/PQ validations, including test method validations, and documenting in written final technical reports

* Ability to travel up to 10% to customer and supplier sites