Vacancy Description
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...
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...
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