Bilingual Hardware Leader for Medical Devices

≪Job Overview & Key Highlights of the Position≫

• Lead the end-to-end development of medical device hardware, from requirements definition and product development through to lifecycle management.
• Drive product development for a leading Japanese medical device manufacturer, contributing to patient well-being and the future of healthcare through innovative technologies.
• Play a key role in expanding a new business as a core team member, with career advancement opportunities to Senior Architect and Principal Architect positions.
• Enjoy 120+ days off per year, a five-day workweek with weekends off, online internal training, and a retirement age of 65 with no mandatory retirement for managerial positions.

【Project Overview and Responsibilities】
Customer is a global leader in advanced medical technologies, with a strong focus on dialysis systems and healthcare solutions that support patients’ lives every day. With decades of experience in hemodialysis, they continue to innovate in blood purification and fluid management, maintaining the highest standards of safety, precision, and reliability. Their high-quality, user-friendly devices are trusted by medical professionals worldwide, from hospital care to home treatment. Guided by a deep sense of responsibility and continuous improvement, the customer is committed to enhancing patient well-being and contributing to the future of healthcare through innovation and collaboration.

A Hardware architect for medical devices serves as a senior technical leader who guides the design, development and life cycle management of various diagnostic and monitoring medical devices, ensuring adherence to both technical and regulatory standards. Candidates must possess strong system engineering skills and the ability to interface directly with customers to understand their needs and pain points. They will be responsible for providing engineering solutions, spanning from requirement gathering to product realization, and will function as a Product Owner/System Architect. In addition to their core hardware/software expertise, candidates must effectively manage all system elements and collaborate with offshore hardware, software, and mechanical teams to ensure customer satisfaction during delivery. Furthermore, candidates should develop proposals to expand customer engagement. Experience with renal devices (dialysis) is highly preferred.

Your expertise will be crucial in delivering solutions that satisfy customers and users while also generating significant value for Quest Global's business investments. The ideal candidate will exemplify leadership and serve as an engineering mentor, working collaboratively with cross-functional teams to design, develop, and implement product engineering solutions.

■Hiring Background：
We are seeking an Hardware Architect for the Japan region, who acts as a SPOC to all the divisions of a major Medical Devices customers. Currently we don’t have a resource to play this role and there is a huge demand for such a position in view of the growing Embedded Product Development business.

■Growth Opportunity：
Excelling in this position will enable you to advance to a higher-level role as a Senior Architect and subsequently as a Principal Architect, accompanied by increased responsibilities and the possibility of a higher salary. Additionally, there may be opportunities to transition into different roles within other departments or functions, such as in Sales, Delivery, and various Leadership positions that contribute significant value to Quest Global's business investments.

■Attractive Points：
An opportunity is available with a leading Japanese medical device company for a long-term and scalable engagement. As this is a new business, the selected candidate will become a core member, contributing significantly to the company's growth.

■What Makes Us Attractive：
Quest Global distinguishes itself by providing engineering services rooted not only in "what" is being done, but also in the "why" behind it. While our core business is engineering, what we are truly creating is a brighter future. For over 25 years, we have tackled some of the world’s most complex engineering challenges. Our team—driven by a deep sense of curiosity—employs unconventional approaches to turn the impossible into reality.

【Employment type】
full-time employee
※Trial period: 3 months, no change in duties or benefits

【Salary】
Negotiable based on experience
※Full annual salary system (1/12 paid monthly)

■Overtime allowance
■Salary increment once a year

【Working Hours】
According to company regulations.

【Work Location】
Higashimurayama, Tokyo
■Access：13 minutes walk from Higashimurayama station
■Measures to prevent passive smoking: Yes (no smoking indoors)

【Vacations】

• Total holidays: over 120 days off per year
• 2-day weekend system (Saturday and Sunday)
• National Holidays
• New Year holidays
• Paid vacation
• Prenatal and post-natal leave
• Childcare leave
• Nursing care leave
• Bereavement leave

*Holidays and vacation days may change depending on the work place you are stationed. Since they are all major manufacturers, most have generous annual vacations

【Welfare】

• Commuting allowance (up to 20,000/month)
• Equipped with various social insurance
  ・ Welfare pension
  ・ Health insurance (Tokyo Information Service Industry Health Insurance Association)
  ・ Employment insurance
  ・ Worker's Accident Compensation Insurance
• Health checkup (health checkup for dependents, medical checkup, gynecological checkup, etc.)
• Retirement age is 65 years old *No mandatory retirement age for managerial positions
• Referral recruitment system (with benefits)
• In-house training system (online)

【Must Have】

• Should know Product development workflow especially Hardware design & development.
• Experience in Schematics entry tool (Cadence Allegro/Mentor Graphics/Zuken/Altium), component selection, power components like DC-DC converters, low voltage signal conditioning circuitry design, transducers interface designs, component tolerance analysis.
• Should have hands on experience on architecture like 8/16/ 32-bit processor-based design & memory interfaces (SDRAM, Flash)
• Technical documentation skills- experience in preparing Specification & Test procedures of hardware assemblies.
• Testing experience including board bring up, Product test procedure, EMI/EMC Compliance Testing, Knowledge of test equipment like oscilloscopes, Multimeter, programmable test loads etc
• English – Business-level proficiency (conversation, reading, writing, etc.)
• Japanese – Native level / JLPT N2 or above (Good communication, reading, writing and presentation skills required)

【Good to Have】

• Medical device Product Standards- IEC60601-1, Medical device Product development lifecycle process & documentation. Awareness in Production Information Management (PIM) & Product Life Cycle Management (PLM) Tools.