Product Engineering Architect

Job Description

Appealing Points:

• Leadership in Cutting-Edge Medical Device Development: Take charge of the full product development lifecycle—from electronic circuit design to risk management—contributing to the creation of high-quality medical devices that improve lives.
• Global and Cross-Functional Collaboration: Work closely with R&D, mechanical, and software teams in a global environment, driving compliance with international standards such as FDA, ISO 13485, and PMDA.
• Culture of Mentorship and Continuous Improvement: Lead and develop a high-performing engineering team in a company that values innovation, quality, and regulatory excellence, while fostering personal and professional growth.

Annual Salary: 8 Million yen and Above

Job Responsibilities:

• Embedded Hardware Skills: Support customer in Electric circuit design (Analog, digital) and PCB design, Selection and evaluation of electricity and electronic components, EOL services for existing product parts (change of design etc.), Various evaluations of products, such as EMC and EMI, Release of drawing related to electricity and electronic components
• Design Controls: Implement and maintain robust design control processes in accordance with 21 CFR Part 820 and ISO 13485, ensuring traceability from user needs to final product
• Mentorship & Team Development: Build and mentor a high-performing engineering team, promoting a culture of innovation, compliance, and continuous improvement
• Cross-Functional Leadership: Collaborate with R&D, mechanical, electrical, and software engineering to deliver high-quality medical devices, Managing and Reporting key KPIs to senior management, Manage the internal and external stakeholders effectively, Work as a SPOC for external stakeholders and internal leadership team
• Product Development Lifecycle Management: Lead the full product development lifecycle (PDLC) including user needs identification, design input/output, design verification and validation (V&V), design transfer, and design history file (DHF) management
• Risk Management: Lead risk analysis activities using FMEA, Fault Tree Analysis (FTA), and ensure compliance with ISO 14971 for medical device risk management
• Regulatory Compliance: Ensure all engineering processes comply with ISO 13485, FDA 21 CFR Part 820, PMDA, and other relevant standards
• Change Management: Oversee engineering change orders (ECOs) and configuration management throughout the product lifecycle
• Operations Management: Establish strong operating mechanisms to track progress, identify issues, overcome obstacles, and define recovery plans

Job Qualifications:

• B.E/B.Tech (Electronics/Electrical) with 20+ years’ relevant experience
• High knowledge and practical experience in electrical design (analog/digital circuit &PCB)
• Several years of hands-on experience in leading medical devices / products development / life cycle management projects
• Strong technical background in R&D engineering disciplines (e.g. electronics, mechatronics)
• Strong knowledge and understanding of medical device regulatory standards
• Excellent communication skills and handling of stakeholders
• Excellent integral (cross functional) stakeholder/perception management skills
• Very good people management skills
• 10+ years of experience in product engineering, with at least 5 years in a leadership role within the medical device industry
• Experience in collaborative development within a team

Good to Have

• Experience with digital health technologies or connected medical devices
• Experience working in a global matrix organization
• Experience in the medical equipment, weak current, and automotive equipment industries
• Knowledge and experience of FPGA or MCU programming
• General knowledge of medical device-related laws (PMD Act, Personal Information Protection Act, IEC, ISO, etc.)
• Knowledge of the safety of medical equipment, including X-rays and strong magnetic fields
• Business level English skills (conversation, reading comprehension, writing, etc.)
• Knowledge of Lean Manufacturing and Six Sigma methodologies
• PMP or equivalent project management certification
• Experience in embedded software and mechanical project management.

Language Skill: Business level japanese (N2 and above) and business level english

Company Description:

We are a global engineering organization dedicated to building a brighter future. What sets us apart is not just what we do, but why we do it. We believe engineering has the power to solve today’s challenges and pave the way for a better tomorrow. For over 25 years, we’ve been a trusted partner in tackling the world’s toughest engineering problems. Headquartered in Singapore, we operate in 17 countries with 67 global delivery centers and offices, supported by a team of 17,800+ exceptional professionals who make the impossible possible every day.