Medical Device Product Engineering Architect
Location: Higashimurayama, Tokyo, Japan
Work model: On-site (customer-facing role)
Domain: Medical Devices / Embedded Systems
This is a senior technical leadership role responsible for the architecture, design, and lifecycle delivery of embedded medical devices used for diagnostics and monitoring. As a Product Engineering Architect, you will act as system architect and product owner, translating customer needs into robust engineering solutions and guiding products from requirements definition through realization and delivery. The role requires deep embedded systems expertise, strong systems engineering capability, and the ability to collaborate directly with Japanese medical device manufacturers as well as offshore hardware, software, and mechanical teams. Experience with kidney or dialysis devices is a strong advantage.
Responsibilities
Lead system architecture, design, and technical direction for embedded medical devices
Own the end-to-end engineering lifecycle, from requirements through product realization
Act as technical SPOC for customer engineering teams
Translate customer needs into clear system and product requirements
Coordinate and guide offshore development teams (hardware, software, mechanical)
Ensure compliance with technical and regulatory expectations
Review architecture, design, implementation, verification, and validation activities
Provide technical leadership and mentorship to embedded engineers
Support proposal development and expansion of customer collaboration
Present technical solutions, risks, and progress to stakeholders
Ensure customer satisfaction upon delivery and system integration
Requirements
15+ years of embedded software development experience
Bachelor’s degree in a relevant engineering field
Ability to work bilingually in Japanese and English
Strong systems engineering mindset with ownership mentality
Proven experience coordinating with customers and offshore teams
Demonstrated ability to mentor engineers and set technical standards
Expert-level knowledge of Embedded C
Experience developing embedded software on MCU / SoC platforms
Hands-on experience with OS / RTOS / QNX
Strong background in:
System architecture and design
Unit testing, verification, and validation
Multi-threaded applications and IPC mechanisms
Scheduling and memory management
Experience with sensor control and motor control software
Deep understanding of communication protocols:
SPI, I2C, CAN, Ethernet, USB
Basic hardware knowledge:
Board bring-up and diagnostics
Debugging via JTAG / SWD
Nice to have:
Embedded GUI development experience
Experience in medical device embedded software (5+ years preferred)
Familiarity with medical regulatory standards:
IEC 62304
IEC 62366
IEC 60601-1-6
ISO 14971
Experience working on regulated medical products from concept to delivery
Benefits
A core architect role in a newly expanding medical device engineering business
Long-term engagement with leading Japanese medical device manufacturers
High visibility and influence on product direction and customer relationships
Career progression toward Senior Architect / Principal Architect roles
Opportunity to move into technical leadership, delivery, or business-facing roles
Work on complex, safety-critical embedded systems with real-world impact
DE&I
We value diversity, equity, and inclusion in our workplace. We encourage applications from talented individuals of all backgrounds, experiences, and identities. Your unique skills and perspectives will contribute to smarter decision-making and stronger outcomes for our stakeholders and clients. Bring your authentic self and be part of our journey.
- Locations
- Higashimurayama
- Employment type
- Full-time
About Salve.Inno Consulting
Bringing a personalized approach to connecting exceptional talent with unique opportunities. Specializing in recruitment for diverse roles, leveraging extensive experience and innovative strategies to find the perfect match for any business needs. Collaboration builds a stronger, more successful future – one strategic hire at a time.