Job Overview
As a Software/AI Medical Device Test Engineer, you will serve as the final guardian of product safety by ensuring medical device software and AI systems meet international safety and regulatory standards. You will evaluate innovative software technologies—such as deep learning, image processing, and AI algorithms—to help bring safe, effective products to the global healthcare market.
You will work across a diverse range of projects based on standards such as IEC 62304, ISO 14971, and FDA guidelines, in collaboration with both domestic and international clients.
Tasks include reviewing documentation, managing testing projects, and providing technical insights into software and AI functionality and risk.
Your Qualifications
Mandatory
• Bachelor's degree or higher in Mathematics, Information Engineering, Electrical Engineering, IT Security, or a related field
• Native-level Japanese and Intermediate-level English (TOEIC 600+ guideline)
• Practical experience in any of the following:
1. Development of software or generative AI (preferably in the healthcare field)
2. Design and development of algorithms such as deep learning, machine learning, or image processing
3. AI development using tools such as Python, PyTorch, TensorFlow, or Keras
Preferred
• Experience designing or building AI algorithm architecture
• Software development in C/C++
• Experience in image AI research or computer vision
• Familiarity with medical device regulations and standards (IEC 62304, ISO 14971)
• Experience in project management or team leadership
Ideal Candidate
• Passionate about technology, innovation, and safety
• Interested in supporting medical device development from a regulatory and quality standpoint
• Enjoys solving problems with precision and attention to detail
• Eager to learn and grow in a dynamic, international team environment
• Motivated to contribute to socially impactful work, helping bring safe products to patients and clinicians
Main Responsibilities
• Evaluate software documentation including requirement specs, test cases, test results, and risk management files
• Create detailed bilingual (JP/EN) test reports
• Collaborate with clients through meetings and seminars (domestic and international)
• Conduct and manage test projects for medical device software and AI systems
• Support laboratory quality system maintenance and respond to external/internal audits
• Answer technical inquiries and assist the sales team in creating quotations
• Help develop test methods aligned with the latest technologies
• Support training and mentoring of engineers (depending on experience)
Attractive Points
Exposure to a Wide Variety of Technologies
You’ll work across a broad spectrum of advanced software and AI medical products from multiple manufacturers, gaining a wide range of technical and regulatory experience.
Early Project Ownership
From early on, you’ll be entrusted with managing entire testing projects, allowing you to gain valuable project management experience.
Global Collaboration
Work directly with international TÜV SÜD offices, including Germany. This role offers opportunities to improve your language skills and gain exposure to global standards and clients.
Work Conditions
• Working Hours: 9:00–18:00 (8 hours/day), 1-hour break
• Flextime System: Core time 11:00–16:00
• Days Off: 120+ days annually, including weekends, national holidays, sick leave, long-service leave, etc.
• Benefits: Social insurance, retirement benefits, travel allowance, telecommuting, technical training, internal mobility system
• Paid Leave: Up to 12 days in the first year depending on entry month; separate sick leave available from Day 1
• Work Attire: Business casual
Selection Process
Resume screening
1st online department interview
Aptitude test (SPI) and TOEIC
2nd interview (department + HR)
Job offer