• Senior Project Engineer

    所在地 JP-Tokyo
    ジョブID
    10869
    求人数
    1
    カテゴリー
    Engineering
  • 職責

    医療機器関連製品の製品安全に関する評価・認証業務

    <具体的な業務内容>

    製品安全規格・規制に関する国内外からのお客さまからのお問い合わせへの対応

    お客さまの製品サンプルを預かり、規格に基づいた構造評価を実施し試験プログラムを決定

    試験部門の結果を元にレポートを作成し、安全基準を満たすか評価し、認証を行う など (以下詳細説明参照)

     

    Under minimal supervision, independently manages execution and timely completion of engineering projects in multiple product categories by analyzing project scope and determining project specifications, establishing test programs for complex product investigations, and preparing reports for clients. Develops UL requirements, test methods, and test equipment for complex, new or unusual products. Exercises Project Handler Signature Authority as Project Handler of record responsible for opening, maintenance, completion, and closing of assigned new work engineering projects. Exercises Review Signature Authority as assigned as Reviewer of record responsible for initial review, status review, and final technical review of all new work engineering projects.

    • Independently determines project scope, develops a preliminary plan of investigation, and determines project specifications such as cost, time, and sample requirements by analyzing client input, available supplemental data, and product construction. Projects may include frequent travel to conduct or witness tests at client sites.
    • Initiates communication with clients to promote and explain the benefits of new and existing services. Follows up on contacts from clients. Communicates with clients to discuss technical issues, explain UL procedures and requirements, convey project cost, and negotiate completion date and sample requirements. Acts to address client concerns and to resolve complex client issues. Provides technical assistance to clients in reference to product inspection and follow-up services.
    • Establishes appropriate test programs by reviewing files and manufacturer's information, examining samples, and applying UL requirements. Determines areas in which the product is not in compliance with UL requirements or of any changes in project scope or specifications, and notifies client.
    • Coordinates complex laboratory activities by preparing data sheets and instructions to technicians and by establishing completion dates. Coordinates administrative aspects of project management. Serves as Project Handler of record and signs as Reviewer of record as assigned.
    • Communicates project status and results to clients through frequent contact and by preparing reports. Prepares Follow-Up Service Procedures and information pages.
    • Integrates continuous improvement concepts and techniques into all aspects of the job.
    • Resolves complex engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of the variations.
    • Develops UL requirements for testing products beyond the scope of existing standards, or those involving unique features requiring frequent use of independent judgment. Develops special test methods and test equipment. Coordinates and/or performs File Reviews. May represent UL on technical committees and/or industry-related functions such as seminars and trade shows.
    • May provide direction as a Primary Designated Engineer or Designated Engineer for specific product categories.
    • Directs and reviews work of assigned staff. Trains office, field, and/or laboratory staff and entry level engineers. Provides technical assistance in several product categories, operations or systems to laboratory and/or field staff.
    • Performs other duties as directed.

    資格

    • 大学卒以上(理系)
    • IEC60601-1の規格知識があり、実務経験が2年以上
    • 英語レベル TOEIC 600程度以上
    • 医療機器業界でエンジニアとして製品安全に関する経験

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