About
Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.
A Day in the Life
Position: Complaint Returned Products Engineer (Complaint Analysis QA @ Tokyo)
Location: Heiwajima, Ota-ku, Tokyo (nearest station: Ryutsu Center)
About the department
Japan Failure Analysis belongs to QA (Quality Assurance) and is connected both to the global QA department and, on a dotted-line basis, to Japan's QA department. The main work is, for all medical devices sold by Medtronic in Japan (including former Sofamor Danek and Covidien products), to handle complaint/defect products returned from the market after sale: comparing registered complaint information against the condition of the returned complaint item, and performing visual inspection, non-destructive testing, and log data extraction. Some cases are fully investigated in Japan; others are sent to overseas manufacturers for investigation.
In Japan, only Japanese complaint items are handled due to various regulatory considerations, but a sister team within the same organization is located in Illinois, USA, where they inspect complaint items returned from Japan and other countries.
As the scope of products for which inspection is completed in Japan expands, one additional headcount has been approved.
Job duties
When a complaint arises for a post-market product sold to a medical institution and the item is returned, the work involves checking the returned item for reproducibility of the issue and any quality abnormalities, identifying the cause of the defect as far as possible, and recording findings to support future improvement. This includes visual inspection using digital cameras and microscopes, log extraction and voltage measurement using dedicated software and equipment, and, depending on the product, disassembly to check internal parts and circuit boards. Medical devices handled may include single-use products. Some products may have dried blood, tissue, or bodily fluids attached, so comfort handling such items is a prerequisite (contamination countermeasures are in place, and return of products used on patients with infectious diseases is strictly prohibited). Because the number of products is very large, OJT is conducted per product. This is not a repair business, so inspection/repair work on medical devices is not performed, but basic knowledge of inspection/repair content and device structure must be learned.
•Checking complaint information for assigned products
•Inspection (visual photography, non-destructive testing, data extraction)
•Product analysis (destructive testing)
•Information sharing with overseas manufacturers (including system input in English, email correspondence, and reading comprehension)
•Communication with sales representatives and others
•Preparing investigation results and related documentation
Must Haves
Job Experience
•2+ years of practical work experience
•Experience in quality, manufacturing, inspection, or repair is a plus
•Experience using Office (Win) at work, especially Outlook and Excel
Skill / Knowledge
•English proficiency (guideline: TOEIC 600+ / reading and writing English). The dedicated system is in English notation. AI translation can be used, but sufficient English ability is needed to judge whether AI translation is appropriate, given nuance differences and technical terminology.
•OA skills (Windows intermediate or above)
•Daily use of SharePoint, MS Teams, Outlook, Excel, Power BI. Knowledge of Word, Power Automate, VBA is a plus.
Competency
•Cooperativeness and communication skills (since individual skills and experience can cause variation in inspection results, information sharing and discussion within the team is necessary. There is also interaction with other departments with different priorities and overseas colleagues with different cultural backgrounds, requiring understanding of others' situations while fulfilling QA responsibilities)
•No resistance to operating microscopes, checking equipment operation, and disassembly (good at detailed work)
•Motivation to become proficient in handling medical devices, including electronic components and circuits
Education
•Bachelor's degree or higher (any faculty/department)
Nice to Haves
Job Experience
•Experience in the medical industry or in quality, manufacturing, inspection, or repair departments
•Experience in network security-related work
Skill / Knowledge
•Knowledge of information processing or networking
•Knowledge of electronic engineering, clinical engineering, etc.
•English conversation skills (able to participate in meetings in English)
Competency
•Good at assembling/disassembling PCs and other equipment
•Capable of objective thinking and careful handling (quality department experience is not required, but due to the nature of the work, laws and regulations must be complied with; this work frequently requires reviewing one's own work objectively for efficiency and procedural compliance)
Working Style
•You adjust your own attendance or work-from-home/flex schedule according to the progress of your assigned products (e.g., commuting 3 days a week for inspection, working from home 2 days for administrative tasks; or working from home in the morning and commuting in the afternoon). Team members each adjust according to their own circumstances, such as childcare pickup/drop-off times, sharing remote work with a partner, or family caregiving.
•Each product has a dedicated person in charge, but work is shared within the team so others can also handle it. The team strives to build a support system so members can cover for each other when the dedicated person is unable to attend, such as during summer vacation.
Benefits
Medtronic believes that the company's success and employees' growth should go hand in hand, and provides substantial benefits and compensation programs to enhance the financial, physical, and mental well-being of each employee.
•Up to 360,000 yen per year in childcare expense subsidy
•Up to 6 weeks of leave available for family caregiving needs or adoption
•Babysitter and daycare matching service
•Career development including mentor programs and e-learning
•In-house career network supporting women's advancement
•Employee stock purchase plan, etc.
Other
Allowances
•Commuting allowance, overtime allowance, holiday work allowance, etc.
Days off
•Saturdays, Sundays, public holidays, etc.
Leave
•Annual paid leave, sick leave, menstrual leave, maternity leave, etc.
Working hours
9:00–17:30 (basically no overtime)
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
