Manufacturing Process Engineer

Base pay range

$45.00/hr - $47.00/hr

Job Title:
Process Engineer

Location:
Maple Grove, MN 55311

Onsite Role

• Will work cross-functionally to lead process development of complex technologies on new products, drive/develop new business activities and rapid prototyping execution and ensure efficient and effective transfer of products into prod
• Partners with R&D to develop design specifications, draft test methods, and drive material selection.
• Provides Design for Manufacturability (DFM) input to the engineering print package.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and automation.
• Contributes creative, innovative ideas and solutions to solve complex technical problems.
• Proposes or investigates new technologies to pave a path for future business.
• Oversees development builds as well as initial production builds associated with the project using special work requests (SWRs).
• Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
• Prepares and presents technical data and recommendations to project stakeholders at technical reviews to influence business decisions.
• Writes and reviews validation protocols and reports applicable to new processes.
• Executes the functional deliverables associated with the PDP/TDP and Quality System.
• Ensures proper documentation is completed to meet quality systems requirements (e.g. print package, drawing trees, BOMs, routers, process risk documentation, SWRs, process flowcharts, process characterization documentation, validation plans, process verification and validation documentation including TMV and OQ/PQ etc.).
• Collaborates with operations counterparts in manufacturing engineering and quality engineering to prepare for product transfer from development to production for commercialization.

• BS in Engineering and 2-4 years of experience.
• Strong engineering fundamentals, conflict resolution experience, and problem-solving skills.
• Demonstrated ability to develop and drive creative, innovative solutions for both processes and products.
• Open to travel up to 10% of the time which may include vendor visits, supplier visits, or conferences.

• Experience developing and characterizing various types of extruded processes such as free extrusion, over the core, coextrusion, over braid, reel to reel, multi-lumen, and bump extrusion.
• Experience working with polymers – particularly Pebax, Nylon, PEEK, Urethanes.
• Familiarity with how extrusion inputs can impact outputs.
• Demonstrated ability to develop equipment / fixtures from concept to prototype to production.
• Demonstrated use of DFSS tools (DOE, problem solving).
• Experience with mechanical design, automation and controls, and programming.
• Strong understanding of statistics and experience using statistical analysis software tools.
• Medical device or other regulated industry experience including an understanding of the quality system.
• Experience as a technical project lead or responsibilities such as coordinating teams.

Mid-Senior level

Contract

Medical Equipment Manufacturing

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