Project Engineer

1週間前

Tokyo, Japan Gigantes Group

Medical Products Certification Project Engineer


Job Description


The medical device division conducts safety testing, document evaluation, and certification of medical devices and in vitro diagnostic medical devices. Medical devices are required to meet higher product safety standards compared to consumer devices. The organization provides services based on the latest knowledge and technology to support the market release of products with the highest level of safety performance. To meet the needs of customers who deploy medical device businesses globally, it is necessary to deliver medical device certification services based on the latest standard requirements promptly. Although the headquarters is in Germany, the medical device division has established a structure that can provide services as ONE TEAM beyond national and regional boundaries.

The job duties and responsibilities include, but are not limited to, the following:

  • Conformity assessment and testing of medical devices based primarily on safety standards (IEC, EN, JIS, UL, CSA, ISO, etc.)
  • Planning for conformity assessment and testing of medical devices, coordination with testing laboratories, test implementation, and response to customer's witness testing
  • Preparation of technical documents such as test reports based on safety standards, IECEE CB reports, North American NRTL reports
  • Handling customer inquiries, conducting technical meetings and public seminars
  • Project management and communication with relevant internal departments

For the "scope of changes" in job content, please refer to "Regarding the 'scope of changes' in job content/workplace and 'wages'"

Requirements


Required Qualifications and Skills:

  • Degree in electrical or electronic engineering, or equivalent qualifications
  • Minimum 3 years of continuous work experience at the time of application
  • Design and development experience in the medical device field (diagnosis, treatment, or X-ray)
  • Ability to respond flexibly, willingness to make efforts without sparing trouble. Excellent communication skills and ability to carry out work independently and proactively

The following experience and skills will be advantageous:

  • Experience in evaluation or testing using product safety standards in the above fields
  • English proficiency: Experience and ability to prepare reports in English and communicate with internal and external members in English

 

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