Process Development Engineer

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.ResponsibilitiesLead process development and optimization for Class III devices, including IQ/OQ/PQ, TMV, and risk management activitiesDevelop and validate test methods, equipment, and new technologies to improve manufacturing processesDesign and implement automation solutions for jig fixtures to reduce manual interventionEnsure compliance with GMP and ISO 13485, with complete documentation and validation protocolsCollaborate with cross-functional teams to integrate new processes into production and support scalingQualifications5–8+ 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 documentationBackground in biological materials integration desirableProven ability to work independently on validation and process engineering activitiesLean problem-solving mindset with strong communication skills