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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
万円 東京 製薬 研究&開発
募集要項
会社概要 同社は、日本国内において医療技術の研究開発と提供を行っています。特に、革新的な治療法の開発に注力し、がん治療に関する先端的な技術を提供しています。光免疫療法という新しい治療アプローチを用いて、がん細胞を標的とした効果的な治療を目指しています。この技術は、光と薬剤を組み合わせることで、選択的にがん細胞を破壊することが可能です。研究開発においては国内外の専門機関や大学との連携を強化し、臨床試験や実用化に向けた取り組みを進めています。医療分野における革新と患者の生活品質向上を目指し、日々努力しています。
業務内容
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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
応募条件
■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
給与 万円
勤務地 東京
BRSコンサルタント
Elaine Montes
Industrial & Life Science
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