Process Development Engineer – 6 Month Contract (Medical Devices)
We are looking for a Process Development Engineer to join a 6 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.
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
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