Job Requirements

Seeking a visionary and technically adept Product Engineering Architect to drive innovation and excellence in the development of medical devices. This role will lead cross-functional engineering teams, oversee the full product lifecycle, and ensure compliance with global regulatory standards with agreed scope/budget/schedule with high quality deliverables. The ideal candidate will bring a blend of strategic thinking, hands-on engineering expertise, and a passion for improving patient outcomes through technology.

Key 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 componentsDesign 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 an 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.

Work Experience

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.Experience in Embedded software and mechanical project management will be a plus.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 stakeholdersExcellent integral (cross functional) stakeholder/perception management skills.Very good people management skills10+ 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

Preferred Skills:

Experience with digital health technologies or connected medical devices.Experience working in a global matrix organization.Person experienced in the industry of medical equipment, weak electric current and in-vehicle equipmentKnowledge and experience of FPGA or MCU programmingCommon knowledge of the related law of medical equipment (PMD Act, Act on Protection of Personal Information, IEC, ISO, etc.)Knowledge regarding medical equipment safety, such as X-rays, high magnetic field and so onEnglish skill of business level (conversation, reading comprehension, document creation, etc.).Knowledge of lean manufacturing and Six Sigma methodologies.PMP or equivalent project management certification will be a plus