Process Development Engineer

About the role

We are seeking a Process Development Engineer to support the development, validation, and transfer of manufacturing processes for valve-based medical devices and associated delivery systems. This role focuses on early-stage manufacturing readiness, supporting product development activities prior to FDA submission, and ensuring robust, repeatable, and compliant manufacturing processes. This is a Contract position based out of Maple Grove, MN. The role operates within standard working hours and embraces a casual dress attire.

Responsibilities

• Develop, characterize, and optimize manufacturing processes for valves, delivery systems, and related assemblies.
• Support new product introduction (NPI), design transfer, and early manufacturing builds.
• Define process flows, assembly methods, tooling concepts, and work instructions.
• Plan, author, and execute IQ/OQ/PQ process validations and Test Method Validations (TMV).
• Perform Design of Experiments (DOE), process characterization, and capability studies.
• Generate validation protocols