Senior Process Development Engineer

Industry

Engineering

Advert ID

FOX_BBBH22455

Location

Minneapolis

Job Type

Permanent

Hours

Full-Time

Salary Range

USD100000-130000 per year

No. of Openings

1

Branch Information

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

ContactNumber

612-630-1200

Job Description

Do you want to help drive forward the manufacture of innovative medical devices that directly impact patients' lives?



Manpower Engineering is partnering with a global industry leader in molded components and assemblies for the medical device industry. The company had their best year in 2020 and is now hiring for a Senior Process Engineer to join their successful team.



Be part of an organization that offers a fun, collaborative environment, values its employees and provides excellent opportunities for career advancement!



Summary:



The Senior Process Engineer will lead process development in order to maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs and changeovers. This role will ensure project outcomes are fully transferable to manufacturing and perform to the highest customer standards.



Responsibilities:



* Coordinate efforts to design, develop and validate manufacturing processes using tools such as Design Of Experiments (DOE), Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), and capability analysis.

* Develop manufacturing plans for products/components from initial idea, through approved design, procurement, process development, process verification and successful implementation into manufacturing.

* Improve manufacturing processes through review of all engineering deliverables for technical accuracy and adherence to engineering standards and project schedules.

* Conduct FAT, IQ, OQ and PQ qualifications for molds and/or equipment and molding processes. Coordinate measurement and dimensional studies.

* Write Validation and Qualification project reports when needed for each new component that transfers to production.

* Drive advancement of processing techniques to support the long-term vision of growth and cost savings.

* Oversee research and development of new manufacturing equipment, processes, policies, standard operating procedures and work instructions.

* Lead and support Tooling PM program with documentation and support operations to sustain it for molding processes. Lead tool design improvements/changes.

* Develop capital budgets, product cost requirements and appropriations requests.

* Perform investigation of root cause analysis and implement corrective action as it pertains to customer complaints and internal non-conformances.

* Devise new approaches to problems while working closely on processes to qualify/sustain tools, troubleshoot issues and enhance operations.

* Instruct others, formally or informally, regarding manufacturing related skills or knowledge and assist in the training of employees on new processes or systems introduced to the company.



Qualifications:



* Bachelor's Degree in Mechanical, Chemical or Plastics Engineering from an accredited program.

* Minimum of 8 years' first-hand experience in the processing and assembly of silicone or plastic injection molded components. Preferred experience in the medical device industry.

* Strong knowledge of Good Manufacturing Practices (GMP), ISO standards, Lean manufacturing concepts and familiarity of FDA regulations is a plus.

* Solid understanding and experience executing complex Design of Experiments (DOE's).

* Excellent communication skills for making persuasive presentations to peers, subordinates, management, and customers.

* Strong ability to train and develop engineering/technical employees at all levels