Medical Device R&D Engineer

Location Tokyo
Discipline Life Science
Job type Permanent
Salary Negotiable
Reference 48746

【COMPANY OVERVIEW】

Global biotechnology company, Setagaya-ku, Tokyo

 

We are looking for an engineer to lead the full lifecycle development of medical devices, with a strong emphasis on upstream design transfer. This role blends hands-on technical responsibilities—such as design, prototyping, and verification—with cross-functional collaboration and project management. You will be instrumental in bringing innovative medical technologies to market, overseeing both engineering execution and project delivery.

 

【JOB RESPONSIBILITIES】

  • Lead planning and execution of medical device design, prototyping, verification, and commercialization efforts

  • Identify and address technical challenges by developing innovative or optimized solutions

  • Design and conduct testing to evaluate product performance, reliability, and safety

  • Oversee design control processes, including risk management and usability engineering

  • Collaborate cross-functionally with teams such as Marketing, Regulatory Affairs, and Quality Assurance

  • Coordinate with contract manufacturers to support and manage production activities

  • Prepare technical documentation and assist with regulatory submissions to ensure compliance with medical industry standards

【REQUIREMENTS】 

  • Proven experience in medical device design and product development

  • Skilled in generating development documentation within a Quality Management System (QMS)

  • Solid understanding of ISO 13485 (QMS for medical devices) and ISO 14971 (risk management) standards

  • Proficient in business-level English, with strong written and verbal communication skills

 

【WELCOME SKILLS AND EXPERIENCE】

  • Experience in developing optical devices such as endoscopes, optical fibers, and laser systems

  • Background in manufacturing engineering, including process development, optimization, and quality control

  • Proven track record in leading projects or managing cross-functional engineering teams