About the Job
Luxshare is a global leader in advanced manufacturing and technology solutions, with a growing footprint in the medical device sector. As part of our strategic expansion, we are establishing a Singapore-based engineering hub to enhance our global product development and manufacturing capabilities.
We are seeking a Senior NPI Engineer to lead the industrialization of complex medical devices from design transfer through to full-scale production. This role is critical in ensuring robust, compliant, and scalable manufacturing processes across Luxshare's global manufacturing network.
You will serve as the bridge between R&D and manufacturing, driving Design for Manufacturing (DFM), process development, and production readiness to enable successful product launches.
Key Responsibilities
- Lead end-to-end NPI programs from design transfer through production ramp-up
- Drive Design for Manufacturing (DFM) and Design for Assembly (DFA) to optimize product manufacturability
- Establish and qualify production lines, including process flow, equipment selection, and line layout
- Plan and execute pilot builds (EVT, DVT, PVT) and ensure readiness for mass production
- Develop and release manufacturing documentation (work instructions, SOPs, process flows, BOMs)
- Collaborate cross-functionally with R&D, Quality, Operation, and Procurement teams globally
- Ensure compliance with ISO 13485, FDA QSR, and GMP requirements
- Perform risk assessments (FMEA) and implement mitigation strategies
- Lead process validation activities (IQ/OQ/PQ) and ensure audit readiness
- Manage engineering changes (ECO/ECN) and maintain configuration control
- Troubleshoot manufacturing issues and drive root cause analysis and CAPA
- Engage suppliers and contract manufacturers for component qualification and process readiness
Key Requirements
- Strong understanding of the medical device product lifecycle and regulatory expectations
- Hands-on experience in manufacturing process development and line setup
- Proven ability to manage multiple NPI programs in a fast-paced environment
- Strong analytical thinking with structured problem-solving capability
- Excellent communication and stakeholder management skills
- Professional working proficiency in Mandarin a plus
Qualifications & Education
- Bachelor's or Master's degree in Mechanical, Electrical, Biomedical Engineering, or related field
- 5–8+ years of experience in NPI, manufacturing, or process engineering within the medical device industry
Project & Delivery Experience
- Demonstrated success in launching medical device products into mass production
- Proven experience in design transfer and manufacturing scale-up
- Hands-on leadership in pilot builds and production ramp phases
- Track record of delivering projects on time, within cost, and to quality standards
Technical & Leadership Experience
- Deep expertise in process development, tooling, and equipment qualification
- Strong knowledge of validation (IQ/OQ/PQ) and risk management (FMEA)
- Familiarity with Lean Manufacturing, Six Sigma, and continuous improvement methodologies
- Experience working with global suppliers and contract manufacturers
- Ability to lead cross-functional teams and influence stakeholders without direct authority
Why Join Luxshare
- Build and scale next-generation medical device manufacturing capabilities in Singapore
- Work on high-impact, innovative healthcare technologies
- Be part of a fast-growing global organization with strong execution capability
- Access to career growth, leadership opportunities, and international exposure
Additional Requirement
- This role may require frequent travel to suppliers or manufacturing sites.
