Senior Manufacturing Engineer
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.
