Job Title: Product
Engineering Architect – Medical Devices (Multi Industry - MedTech)
- Location: Otawara City, Tochigi, Japan
- Industry: Engineering; Computer Hardware
- Work Type: On-Site; Full-time
Business Content /
Responsibilities:
- Embedded Hardware Engineering
- Electrical circuit design (analog & digital)
- Customer support for printed circuit board (PCB) design
- Selection and evaluation of electrical and electronic components
- EOL (End of Life) services for existing product parts (design changes, replacements, etc.)
- Conduct various product evaluations including EMC and EMI
- Creation of drawings related to electrical and electronic components
Design Control:
- Implement and maintain a robust design control process compliant with 21 CFR Part 820 and ISO 13485
- Ensure full traceability from user needs to final product release
Mentorship & Team
Development:
- Build, mentor, and lead high-performing engineering teams
- Promote a culture of innovation, compliance, and continuous improvement
Cross-Functional Leadership:
- Collaborate with R&D, Mechanical, Electrical, and Software Engineering teams
- Manage and report key KPIs to executive leadership
- Serve as SPOC (Single Point of Contact) for both external stakeholders and internal leadership
- Manage internal and external stakeholder relationships effectively
Product Development
Lifecycle Management:
- Lead the full Product Development Lifecycle (PDLC) including:
- User needs identification
- Design input/output
- Design verification & validation (V&V)
- Design transfer
- Management of Design History Files (DHF)
Risk Management:
- Lead risk analysis activities using FMEA and Fault Tree Analysis (FTA)
- Ensure compliance with ISO 14971 – Medical Device Risk Management
Regulatory Compliance:
- Ensure engineering processes comply with:
- ISO 13485
- FDA 21 CFR Part 820
- PMDA requirements
- Other applicable medical device regulatory standards
Change Management:
- Oversee Engineering Change Orders (ECOs) and configuration management throughout the product lifecycle
Operational Management:
- Establish strong operational mechanisms to track progress, identify issues, develop recovery plans, and ensure project execution
About the Team
- The Medical Device Product Engineering Architect is a senior technical leader responsible for:
- Leading design, development, and lifecycle management of diagnostic and monitoring medical devices
- Ensuring technical and regulatory compliance
- Overseeing all design documentation including:
- Requirements specifications
- Schematic captures
- PCB files
- Test plans
- Leading risk management, verification, and validation plans
- Acting as an engineering mentor and collaborating with cross-functional teams
- Providing technical leadership and creating significant value for our client’s company medical device business
Role Overview:
- A Product Engineering Architect for medical devices serves as:
- A senior technical leader guiding full lifecycle management of medical device products
- A key contributor in design, development, documentation, V&V planning, and risk management
- A mentor and liaison engineer connecting on-site Japan teams with offshore India teams
- A valuable contributor to our client’s company business growth within the Medical Devices division
Hiring Background:
- This is a newly created role to support the rapid expansion of embedded product development in the Medical Devices business unit in Japan
- The role acts as a SPOC for major Japanese medical device customers
- Establishes a technical liaison function to support increasing customer demands in the region
- Plays a strategic role in strengthening our client’s company medical device capabilities and partnerships
Attractive Points of the
Position:
- Serve as Technical SPOC for all Medical Business Unit customers in Japan
- Lead and support cutting-edge medical device engineering initiatives
- Work closely with an offshore India team, utilizing bilingual communication skills
- Play a critical role in the future expansion of our client’s company medical device division
- Opportunity to work in a hybrid global engineering environment
- Direct involvement in high-impact medical device innovation
Growth Opportunity / Career
Path:
- Clear career progression to Senior Architect → Principal Architect
- Potential to transition into:
- Sales
- Delivery
- Leadership roles
- Other cross-functional roles adding significant value to Quest Global
- Increased responsibility, influence, and compensation with advancement
Flexible Work Arrangement:
- Remote work from Tokyo or Kanto suburban areas is available (WFH negotiable)
- Travel to customer location in Nasu / Otawara, Tochigi required as needed
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