Senior Quality Engineer

Senior Design Quality Engineer

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 provide world-class medical device design and development services to clients across the global market.

We are seeking a Senior Design Quality Engineer to serve as the quality lead across all client design and development programs. This role is critical in ensuring that all deliverables meet the highest standards of safety, reliability, and regulatory compliance, while protecting both our clients interests and Luxshare's reputation as a trusted design service partner.

In addition to project-level design quality responsibilities, this role will own and manage Luxshare Singapore's Quality Management System (QMS), ensuring it is established, maintained, and continually improved to meet ISO 13485, EU MDR, and FDA 21 CFR Part 820 requirements.

As a design service provider, Luxshare does not own client device designs or regulatory submissions. This role is responsible for ensuring the quality, compliance, and integrity of all design service deliverables throughout each engagement.

Key Responsibilities

• Lead design quality activities across the full product lifecycle, from user needs and design inputs through design verification, validation, and design transfer

• Establish and maintain the Design History File (DHF) and technical documentation in compliance with ISO 13485, EU MDR, and FDA 21 CFR Part 820

• Drive Design and User FMEA (dFMEA and uFMEA) and risk management activities in accordance with ISO 14971 to identify, assess, and mitigate product risks

• Plan and support design verification and validation (V&V) protocols and reports, ensuring test coverage meets regulatory and design requirements

• Support and lead design reviews to ensure quality gates are met at each phase of product development

• Collaborate cross-functionally with R&D, Operations, and NPI teams to integrate structured quality practices into all phases of design and development

• Ensure all design service deliverables comply with EU MDR, FDA 21 CFR Part 820, ISO 13485, and applicable IEC standards (e.g., IEC 60601, IEC 62304, IEC 62366, ISO 10993), with a primary focus on the US market while also supporting EU regulatory requirements

• Manage the design change control process, assessing the quality impact of design modifications and maintaining configuration control throughout the product lifecycle

• Investigate product and design quality issues, driving root cause analysis (8D/Fishbone/5-Why) and implementing effective corrective and preventive actions (CAPA)

• Lead internal and external audits, client quality reviews, and FDA inspections, ensuring all design service documentation and quality records are complete and audit-ready at all times

• Own and manage Luxshare Singapore's Quality Management System (QMS), including establishing, maintaining, and continuously improving QMS processes, procedures, and records in compliance with ISO 13485, EU MDR, and FDA 21 CFR Part 820

• Drive internal quality training, management review processes, and QMS performance metrics to foster a culture of continuous improvement across the Singapore engineering team

Key Requirements

• Deep understanding of medical device design control requirements under FDA 21 CFR Part 820, EU MDR, and ISO 13485, with working knowledge of applicable IEC standards

• Hands-on experience in design V&V, risk management, and DHF/DMR management within a regulated medical device environment

• Demonstrated ability to establish and manage a QMS from the ground up, including authoring SOPs, managing CAPAs, and leading management reviews in a design services or contract engineering environment

• Strong analytical thinking with structured problem-solving capability

• Strong influencing, communication, and stakeholder management skills across engineering, regulatory, and operations functions

• Professional working proficiency in Mandarin is a plus

Qualifications & Education

• Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Software Engineering, or a related field

• 5–8+ years of experience in design quality, product quality engineering, or quality assurance within the medical device industry

Project & Delivery Experience

• Demonstrated success in supporting medical device products through the full design control lifecycle, from design input to commercial launch

• Experience supporting design transfer quality activities on behalf of client organizations, ensuring completeness and traceability of quality documentation without holding device ownership

• Hands-on leadership of V&V test planning, execution, and reporting across multiple product development phases (e.g., concept, feasibility, design freeze, launch)

• Track record of delivering high-quality design documentation, QMS deliverables, and client quality reports on time and to agreed standards

Technical & Leadership Experience

• Proven expertise in QMS ownership, design control, and DHF/DMR management under ISO 13485, EU MDR, and FDA 21 CFR Part 820, including experience building or operating a QMS within a design services or contract engineering environment

• Strong knowledge of design V&V and risk management (ISO 14971)

• Working knowledge of applicable IEC standards including IEC 60601, IEC 62304, and IEC 62366 (usability engineering), as well as biocompatibility requirements (ISO 10993)

• Understanding of medical device cybersecurity principles (e.g., IEC 81001-5-1, FDA guidance) and cFMEA (Critical Failure Mode and Effects Analysis) is a plus

• Experience with statistical tools for design analysis (DOE, Gauge R&R, SPC), reliability engineering tools (e.g., Weibull analysis, accelerated life testing), and quality data analysis tools (Minitab, JMP, or equivalent) is a plus

• Ability to lead and influence cross-functional design teams, quality forums, and regulatory interactions without direct authority

Why Join Luxshare

• Work on high-impact, innovative healthcare technologies

• Transition and scale next-generation medical device manufacturing capabilities

• 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 customers, suppliers, or manufacturing sites.