Job number: JN Posted:
R&D|Medical Device Development Engineer
最新の医療技術や装置の開発に力を入れている企業です
8 - 11 million yen Tokyo Pharmaceutical Research & Development
Job details
Company overview We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.
Responsibilities
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ポジションについて
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医療機器の設計開発において、上流から設計移管を中心に、開発全体をリードできる技術者を募集します。
設計・検証などの技術的知見に加え、製造委託業者との連携や進捗管理、申請対応などにも広く関与いただきます。
技術とプロジェクトマネジメントの両面から、幅広い視点で革新的な医療機器を市場へと届けていただくことを期待します。
■具体的な業務内容
- 医療機器の設計検討、試作・検証、製品化に向けた開発業務全般
- 技術課題の抽出および、改良または新たな解決策の検討
- 製品性能や安全性に関する評価手法の設計・実施・解析
- リスクマネジメントおよびユーザビリティエンジニアリングを含む設計管理の実施
- 関係部門(マーケティング、薬事、品質保証など)との連携
- 製造委託業者との連携による製造プロセスの調整および技術支援
- 医療規制基準に準拠したドキュメンテーションおよび申請サポート
━━━求める人物像━━━
- チームワークを大切にし、他部署と協力して業務を遂行できる方
- 技術的課題に対し、論理的に考え解決できる方
- 新しい技術に対する探究心と柔軟な発想を持つ方
- 医療現場のニーズを理解し、安全性と効率を両立させた製品開発に情熱を持つ方
━━━━━━━━━━━━━━━#spotlightjob10
Requirements
■必須
- 医療機器の設計・開発経験
- QMSに則った開発文書作成経験
- ISO 13485、14971などの医療機器の規制に関する知識
- ビジネスレベルの英語スキル(文書作成および会議対応)
■歓迎
- 光学関連機器(内視鏡、光ファイバー、レーザーなど)の設計・開発経験
- 生産技術(製造プロセス、工程管理)に関する経験
- プロジェクトリーダー、マネジメント経験
Salary million yen
Location Tokyo
BRS Consultant
Elaine Montes
Industrial & Life Science
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