【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