Manufacturing Engineer

Job description The Manufacturing Engineer owns engineering support for our manufacturing operations. The role takes processes and equipment from specification and validation through scale-up, and then keeps improving them in day-to-day production, while staying compliant with FDA QMSR (21 CFR 820) and ISO 13485. Primary Responsibilities Process development and scale-up Set up new manufacturing processes and improve existing ones. Lead scale-up and commercialization of new processes so they hit targets for yield, capacity, throughput time and productivity. Help design and build lean production lines, with attention to flow, throughput time, material movement, layout and space. Work with R&D, Quality and Operations so products move from development through approval and into production smoothly, on time and cost-effectively. Equipment and validation Own the equipment lifecycle: specification, procurement, installation and validation. Write and run Factory Acceptance Tests (FATs), both on-site and at vendors, for equipment used in processes where we own the product or process design. Write and execute IQ/OQ/PQ protocols and reports for equipment, process and product validations, in line with regulatory requirements. Set up preventive maintenance and calibration programs. Documentation and materials Create and maintain manufacturing documentation: equipment files, pFMEAs, TMVs, bills of materials, part numbers, product routings, manufacturing procedures and logs. Specify and order the components, consumables and materials needed for validation and production. Production support and training Provide daily engineering support to Production, and keep driving better operating performance without compromising regulatory compliance. Lead knowledge transfer for new processes and train product builders and technicians. Qualifications   Bachelor’s degree in engineering (mechanical, biomedical, chemical or manufacturing preferred) or equivalent. 1+ years in a manufacturing or process engineering role. Medical device or other regulated-industry experience strongly preferred. Hands-on experience with process validation (IQ/OQ/PQ), equipment qualification and pFMEA. Strong technical writing skills, with a record of producing protocols, reports and procedures. Execution-focused: comfortable moving between hands-on work and guiding technicians and cross-functional partners.