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

• Bachelors 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

  • 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.