【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