LUXSHARE-ICT Hiring! Full Time Senior NPI Engineer in - Ricebowl

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.