Job Description
The Safety Testing Department within a global certification body’s Medical Devices Division is responsible for conducting safety evaluations, documentation reviews, and certification services for medical devices, measuring instruments, and in-vitro diagnostic (IVD) products. These devices are held to higher safety standards than general consumer electronics.
The organization provides services grounded in the latest knowledge and technologies to support the release of high-safety-performance products. To serve medical device clients operating in international markets, the division delivers prompt and up-to-date certification solutions aligned with current global regulatory standards.
Though the company is headquartered overseas, the Medical Devices Division collaborates across borders as a unified team to ensure consistent service delivery.
Main Duties and Responsibilities(including but not limited to):
Conduct conformity assessments and safety testing based on international standards (IEC, EN, JIS, UL, CSA, ISO, etc.)
Plan and coordinate test activities with laboratories, including on-site testing and support for customer-witnessed evaluations
Prepare technical documentation such as safety test reports, IECEE CB reports, and NRTL reports for North America
Handle customer inquiries and participate in technical meetings and public seminars
Manage projects and facilitate internal communication with relevant teams
Required Skills & Qualifications:
Project management experience and a background in electrical engineering (technical high school level or above)
Experience in the design or development of any of the following:
Spectroscopic analyzers for IVD and calibration standards
Digital multimeters
Measuring devices such as oscilloscopes or spectrum analyzers
Signal generators
Calibrators or laboratory/factory electrical control systems
Analytical equipment like gas chromatographs or mass spectrometers
At least 3 consecutive years of professional experience at the time of application
Ability to work flexibly, responsibly, and proactively
Strong interpersonal and communication skills, combined with a self-motivated attitude
Preferred Qualifications:
Hands-on experience with product safety evaluations or testing using relevant safety standards
English language proficiency, especially in technical documentation and report writing
Employee Benefits:
Comprehensive social insurance coverage (health, pension, employment)
15 paid vacation days granted in the first year
Flex-time system (core hours: 11:00–15:00)
Optional defined contribution pension plan
Access to employee benefits club
Recognition program for long-term service
Paid leaves: sick, child nursing, caregiving, condolence
Parental leave and reduced hours for child care
Financial support for language programs and external learning
Mental health support and counseling services
On-site massage services
Working Conditions:
Working hours: 09:00–18:00 (break: 12:00–13:00)
Flex-time system with core hours from 11:00–15:00
Five-day workweek, public holidays, and year-end holidays (Dec 29 – Jan 3)
Commuting and other allowances provided
Permanent employment (retirement age: 65)
Six-month probationary period
Overtime: approximately 1 to 30 hours per month
Strict no-smoking policy at the workplace
Please refer to the designated section for details regarding job scope, location, and compensation
Work Location:
Osaka.