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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