Process Development Engineer III

Heraeus Group•Fridley, MN

13d•Hybrid

About The Position

As part of the process development team, The Process Development Engineer II will be responsible for creating robust and sustainable manufacturing processes for medical components and devices. As a Process Development Engineer III, you will provide technical leadership for the commercial release of products to production by working cross-functionally through the Medevio product development process. Success in this position requires hands-on process work, data analysis, customer communication, coordination and documentation. We are open to hiring at an Engineer III or Senior EIII level. This position will be based out of Fridley, MN but will require movement between both that site and the White Bear Lake, MN location.

Requirements

Bachelor degree in Engineering or related technical field strongly preferred; other relevant postsecondary education, training, and experience may be considered in lieu of a Bachelor’s degree.
Minimum 5 years of relevant experience required; 1 year of relevant experience may be substituted for a graduated degree and 3 years for a doctorate degree.
Manufacturing or Process Development experience in one or more of the following highly desired: medical devices (delivery systems or catheters), micro-assembly, reflow, laser ablation/welding/marking.
Demonstrated knowledge of Process Development Engineering.
Able to make complex data driven decisions utilizing statistics.
Experience with process validation, installation qualification, and engineering deliverables from the product development process.
Able to identify, execute, and communicate on any technical and/or project workstreams.
Able to communicate complex technical concepts to all audiences including senior management, production employees, and customers.
Demonstrated ability to develop cross-functional relationships and influence to drive results.
Demonstrates strong leadership in communicating and championing the need for continuous improvements and continued change to meet company needs.
Must be willing and able to travel between Fridley, MN and White Bear Lake, MN sites, as needed.

Responsibilities

Lead in the execution of the process design, development, and validation activities for medical devices through the product development process.
Demonstrates consistent understanding in determining solutions for complex problems, process selection decisions, and technical challenges.
Utilizes process characterization skills and tools such as Design on Experiments (DOE), pFMEA, DFM, and statistics to make data driven decisions.
Ensure that proper technical processes are developed, implemented, maintained, and documented to successfully introduce new products into manufacturing.
Lead new tooling/fixturing & equipment identification, procurement, and installation.
Drive execution of these activities to document, qualify or verify tooling or equipment for use.
Creates or leverages documents such as process validation protocols or engineering studies that demonstrate technical rationale for associated decision.
Willing and able to mentor other engineers and promote a culture of feedback.
Works collaboratively with technicians and operators on the production floor to solve technical problems.
Establishes regional relationships and collaborates to ensure best practices utilized.
Other duties may be assigned as required.