Process Engineer

About the Role We are seeking an experienced Process Engineer to join our innovative MedTech company on a 12-month fixed-term contract. Specialising in cutting-edge orthopaedic products, we are at the forefront of medical device manufacturing, utilising advanced laser-based additive manufacturing technologies to deliver life-changing solutions to patients. This is a remote position offering flexibility while working with a dedicated team committed to excellence in medical device development and manufacturing. Key Responsibilities * Lead and support process validation activities across manufacturing operations, ensuring compliance with ISO 13485 and FDA CFR requirements * Develop, implement, and maintain robust manufacturing processes for orthopaedic medical devices using laser-based additive manufacturing technologies * Conduct Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971 risk management standards * Drive continuous improvement initiatives to optimise process efficiency, quality, and compliance * Collaborate with Quality Assurance, Regulatory Affairs, and R&D teams to ensure seamless product development and commercial manufacturing * Prepare and maintain comprehensive process documentation, including validation protocols, reports, and standard operating procedures * Support investigations and implement corrective and preventive actions (CAPA) for process-related non-conformances * Ensure all processes meet stringent regulatory requirements for medical device manufacturing Essential Experience & Skills * Validation: Proven experience in process validation (IQ/OQ/PQ) within a regulated manufacturing environment * MedTech Regulatory Knowledge: Strong understanding of ISO 13485 Quality Management Systems * FDA Compliance: Working knowledge of FDA Code of Federal Regulations (CFR), particularly 21 CFR Part 820 * Advanced Manufacturing: Hands-on experience with laser-based additive manufacturing processes * Risk Management: Demonstrated expertise in PFMEA methodologies and ISO 14971 risk management Desirable Experience * Experience with orthopaedic or implantable medical devices * Knowledge of additional additive manufacturing technologies * Familiarity with design controls and design history file requirements * Experience with statistical process control and data analysis tools