Medical Device Development Engineer

Position Summary

We are looking for an experienced engineer to lead the end-to-end development of medical devices, with a particular focus on upstream activities through design transfer. This role requires a strong foundation in design and verification, as well as hands-on involvement in project management, coordination with contract manufacturers, and support for regulatory submissions. The ideal candidate will be capable of contributing from both technical and project management perspectives to bringing innovative medical solutions to the market.

Responsibilities

• Engage in a wide range of development activities including design planning, prototyping, verification, and preparation for commercialization of medical devices.
• Identify technical challenges and propose improvements or novel solutions.
• Design, execute, and analyze evaluations related to product performance and safety.
• Manage design controls, including risk management and usability engineering activities.
• Collaborate closely with cross-functional teams such as Marketing, Regulatory Affairs, and Quality Assurance.
• Lead collaboration with contract manufacturers to support and optimize manufacturing processes.
• Prepare and maintain documentation in compliance with medical device regulations and support regulatory submissions.

Qualifications

Required

• Experience in the design and development of medical devices
• Familiarity with preparing development documentation in accordance with QMS
• Knowledge of medical device regulations such as ISO 13485 and ISO 14971
• Business-level English proficiency, including authoring documents and leading discussions in meetings

Preferred

• Experience in designing and developing optical-related devices (e.g., endoscopes, optical fibers, laser systems)
• Experience in manufacturing engineering, including process development and production control
• Experience as a project leader or in project management roles

Desired Skills and Attributes

• A collaborative team player who can work effectively across departments
• A logical thinker with strong problem-solving skills to address technical challenges
• Curious and open-minded, with a passion for exploring new technologies
• Deeply committed to understanding clinical needs and developing medical devices that balance safety and efficiency