Reliability and Design Transfer Engineer

Position Summary

We are looking for an engineer to support and lead design transfer activities, ensuring a smooth transition of medical devices from development to external manufacturing partners. The role focuses on reliability design, risk-based verification, and quality assurance, while working closely with global teams to support product improvements and manufacturing readiness.

Key Responsibilities

Lead technical design transfer to contract manufacturing partners Plan and execute reliability design and verification based on risk assessments Prepare and maintain design and development documentation within the quality system Work with cross-functional and global teams on requirements, risk management, and verification activities Conduct reliability and verification testing (e.

g., stress, shelf-life, shipping, environmental) Support technical communication with manufacturing partners and process development Review product issues and feedback to support continuous improvement Requirements Bachelor’s degree or higher in science, engineering, or a related field Minimum of 2 years of experience and knowledge in the relevant medical device industry (Candidates with more extensive experience will be considered for a senior position) Practical experience in design transfer or equivalent technical transfer activities Medical device engineering skills (design and development, technical documentation, product handling, root cause analysis, data analysis, and risk management) Knowledge of ISO 13485 and MHLW Ministerial Ordinance 169 Knowledge of ISO 14971 and related ISO/IEC regulatory standards Experience in production technologies (manufacturing processes and process control) Communication skills sufficient to lead meetings and drive technical discussions in English Ability to read, write, and understand technical documents in English Excellent verbal and written communication skills in Japanese