IVD Project Engineer

勤務地 大阪市
業界・業種 IT
契約タイプ Permanent
給料 Negotiable
参照番号 50111

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.