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JCW Group

Senior Process Development Engineer

JCW Group, Osseo, Minnesota, United States, 55311

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Senior Process Development Engineer – 6–12 Month Contract (Medical Devices)

We are looking for a Senior Process Development Engineer to join a 6–12 month contract within the medical device industry. This role will support manufacturing development and operations, working closely with QA, R&D, and Production teams. The focus is on biological tissue, process development, validation, and characterization for Class III devices.

Base pay range $55.00/hr - $65.00/hr

Responsibilities

Lead process development and optimization for Class III devices, including IQ/OQ/PQ, TMV, and risk management activities

Develop and validate test methods, equipment, and new technologies to improve manufacturing processes

Design and implement automation solutions for jig fixtures to reduce manual intervention

Ensure compliance with GMP and ISO 13485, with complete documentation and validation protocols

Collaborate with cross‑functional teams to integrate new processes into production and support scaling

Qualifications

5–8+ years of process development and manufacturing engineering experience in the medical device industry (Class III preferred)

Strong expertise in validation (IMV, TMV, IQ, OQ, PPQ) and documentation

Background in biological materials integration desirable

Proven ability to work independently on validation and process engineering activities

Lean problem‑solving mindset with strong communication skills

Seniority level Mid‑Senior level

Employment type Contract

Job function Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

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