About

About the RoleWe are seeking an experienced Process Engineer to join our innovative MedTech company for an exciting contract opportunity. 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 12-month contract role offers the perfect opportunity to make an immediate impact in a fast-paced, innovative environment while gaining valuable experience in advanced additive manufacturing and regulatory compliance.This is a remote position offering flexibility while working with a dedicated team committed to excellence in medical device development and manufacturing.Key ResponsibilitiesLead and support process validation activities across manufacturing operations, ensuring compliance with ISO 13485 and FDA CFR requirementsDevelop, implement, and maintain robust manufacturing processes for orthopaedic medical devices using laser-based additive manufacturing technologiesConduct Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971 risk management standardsDrive continuous improvement initiatives to optimise process efficiency, quality, and complianceCollaborate with Quality Assurance, Regulatory Affairs, and R&D teams to ensure seamless product development and commercial manufacturingPrepare and maintain comprehensive process documentation, including validation protocols, reports, and standard operating proceduresSupport investigations and implement corrective and preventive actions (CAPA) for process-related non-conformancesEnsure all processes meet stringent regulatory requirements for medical device manufacturingEssential Experience & SkillsValidatio