Position Overview
We are seeking a Product Reliability & Design Transfer Engineer to lead the transition of newly developed medical devices from development into manufacturing through external manufacturing partners. This role is responsible for driving reliability-focused design, risk-based verification activities, and ensuring product quality and robustness throughout the design transfer process.
The position works closely with global cross-functional teams, including overseas R&D groups, to support project execution and continuous product improvement. In addition, this role contributes to post-market quality by analyzing field issues and feeding insights back into development to enhance product performance and reliability.
Key Responsibilities
Lead technical design transfer activities to ensure smooth and effective transfer of developed products to contract manufacturing partners
Plan and execute reliability engineering activities and design verification based on risk analysis outcomes
Develop, review, and maintain design and development documentation required under medical device quality management systems
Collaborate with global, cross-functional stakeholders to align on user requirements, product requirements, risk management, and verification/validation strategies
Conduct reliability testing, including stress testing, shelf-life studies, transportation testing, and environmental testing
Execute design verification testing in accordance with regulatory and internal requirements
Serve as a technical interface with manufacturing partners, contributing to process design and manufacturability considerations
Analyze customer complaints and product nonconformities, and propose corrective and preventive improvements
Required Qualifications
Bachelor’s degree or higher in science, engineering, or a related discipline
At least 2 years of experience within the medical device industry (candidates with greater experience may be considered for a senior-level role)
Hands-on experience with design transfer or equivalent technical transfer activities
Strong medical device engineering background, including design & development, technical documentation, root cause analysis, data analysis, and risk management
Working knowledge of ISO 13485 and applicable Japanese medical device regulations
Knowledge of ISO 14971 and related international risk management standards
Experience with manufacturing processes, production engineering, or process control
Ability to lead technical discussions and meetings in English
Strong English reading and writing skills for technical documentation
Excellent verbal and written communication skills in Japanese
Preferred Qualifications
Proven experience conducting reliability testing within medical device development
Practical experience with design transfer in a regulated manufacturing environment
Experience working with global teams in English
Prior collaboration with CMOs or external manufacturing partners in a technical capacity
Ideal Candidate Profile
Collaborative team player who works effectively across departments and with external partners
Logical problem-solver who can analyze technical challenges and drive practical solutions
Adaptable and proactive, with a strong willingness to learn new technologies and processes
Motivated by developing safe, reliable, and efficient products that address real clinical needs
Comfortable operating in a global environment and engaging in cross-cultural communication