Senior Manufacturing Engineer

2 weeks ago


Singapur, Singapore Barrington James Full time

Senior Manufacturing Engineer (Medical Devices) – Singapore Position Summary The Senior Manufacturing Engineer is responsible for leading manufacturing process development, optimization, and technical execution to support efficient, compliant, and high-quality production of medical devices. This role works closely with cross-functional teams including Production, Quality, NPI/R&D, and Supply Chain to ensure robust manufacturing processes for both existing products and new product introductions. Key Responsibilities Process Development & Optimizations: Design, implement, and continuously improve manufacturing processes to enhance product quality, yield, throughput, and cost efficiency. New Product Introduction (NPI): Support and lead technology transfer activities from development to manufacturing, ensuring processes are scalable, well-documented, and production-ready. Process Qualification & Validation: Lead and execute equipment and process validation activities including IQ/OQ/PQ; prepare validation protocols, reports, and supporting documentation. Manufacturing Support & Troubleshooting: Provide senior-level technical support to production operations, resolving process issues, reducing variability, and minimizing downtime and defects. Continuous Improvement: Drive Lean Manufacturing, Six Sigma, and other continuous improvement initiatives to eliminate waste and improve operational performance. Documentation & Compliance: Develop and maintain manufacturing documentation including SOPs, work instructions, PFMEA, control plans, and technical reports in compliance with regulatory and quality system requirements. Quality & Risk Management: Support root cause investigations, CAPA activities, and risk assessments; work closely with Quality teams to ensure process robustness and regulatory compliance. Cross-Functional Collaboration: Partner with internal stakeholders, suppliers, and equipment vendors to support tooling, automation, material selection, and process enhancements. Qualifications Education: Bachelor’s degree in Mechanical Engineering, Manufacturing/Industrial Engineering, Biomedical Engineering, or a related technical discipline. Experience: Minimum 5–8+ years of experience in manufacturing engineering within a regulated environment , preferably medical device manufacturing. Technical Skills Strong background in manufacturing process design and optimization Hands‑on experience with process validation and qualification Knowledge of DOE, SPC, PFMEA, and statistical analysis Experience with automation, fixtures, tooling, and equipment integration Strong documentation and reporting skills Regulatory & Quality Knowledge Working knowledge of GMP, ISO 13485, and applicable regulatory requirements. Soft Skills Strong communication, problem‑solving, and project leadership skills with the ability to influence cross‑functional teams. Personal Attributes Self‑driven, detail‑oriented, adaptable, and able to thrive in a fast‑paced manufacturing environment. #J-18808-Ljbffr



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