Process Development Engineer

Job Description:
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.
Responsibilities:

+ Develop, characterize, and optimize manufacturing processes for valves, delivery systems, and related assemblies.

+ Support new product introduction, 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 val...