Manufacturing Engineer – Medical Devices

Our client is a leading local medical device contract manufacturer supporting the development and manufacturing of medical devices for global markets. Working Days: Monday – Friday Working Hours: 8:00am – 5:30pm Location: East area Job Responsibilities • Provide Design for Manufacturability (DFM) and Design for Assembly (DFA) input during product design reviews and prototype development. • Evaluate product designs for manufacturability, assembly feasibility, reliability and cost effectiveness. • Support design transfer activities from R&D to manufacturing for new products. • Develop manufacturing processes, workflows and detailed work instructions for new products. • Develop and validate manufacturing processes using IQ/OQ/PQ methodologies. • Design, build and qualify manufacturing fixtures, jigs, tools and test equipment. • Develop and validate custom equipment, fixtures and manufacturing processes to support production. • Define equipment specifications and support procurement, installation and commissioning of manufacturing equipment. • Develop and validate critical manufacturing tests to ensure product quality and performance. • Support product and process continuous improvement initiatives, including troubleshooting and root cause investigations. • Participate in design and process risk management activities, including dFMEA and pFMEA. • Prepare and maintain process documentation including FMEAs, control plans, work instructions and validation reports. • Support regulatory documentation and maintain audit-ready records. • Collaborate with R&D, Quality, Regulatory, Supply Chain and Operations teams on product and process development. • Provide technical guidance and training to operators, technicians and junior engineers. • Ensure manufacturing processes comply with applicable quality management and medical device regulatory requirements. • Perform other duties as assigned. Requirements • Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Mechatronics or a related discipline. • 3–5 years of experience as a Manufacturing Engineer, Process Engineer or Advanced Manufacturing Engineer supporting product development. • Good understanding of FDA 21 CFR 820, ISO 13485 and ISO 14971 . • Experience in product/device continuous development and transfer; NPI experience will be an advantage. • Hands-on experience with CAD software such as SolidWorks will be an advantage. • Experience with process validation, equipment qualification and manufacturing documentation. • Knowledge of Lean, Six Sigma or continuous improvement methodologies will be an advantage. • Experience with statistical analysis tools such as Minitab or JMP will be an advantage. Interested candidates who wish to apply for the advertised position are encouraged to click "Apply Now" to submit their application. We regret that only shortlisted candidates will be notified. Recruitpedia Pte. Ltd. EA Licence No.: 19C9682 EA Registration No.: R23115655 (Michelle Yeo Swee Xiang)