Medical Device R&D Engineer

職務概要： 

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。 

 

Position Summary： 

We are looking for an experienced engineer to lead the end-to-end development of medical devices, with a particular focus on upstream activities through design transfer. This role requires a strong foundation in design and verification, as well as hands-on involvement in project management, coordination with contract manufacturers, and support for regulatory submissions. The ideal candidate will be capable of contributing from both technical and project management perspectives to bringing innovative medical solutions to the market. 

 

 

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 

 

Responsibilities： 

• Engage in a wide range of development activities including design planning, prototyping, verification, and preparation for commercialization of medical devices. 

• Identify technical challenges and propose improvements or novel solutions. 

• Design, execute, and analyze evaluations related to product performance and safety. 

• Manage design controls, including risk management and usability engineering activities. 

• Collaborate closely with cross-functional teams such as Marketing, Regulatory Affairs, and Quality Assurance. 

• Lead collaboration with contract manufacturers to support and optimize manufacturing processes. 

• Prepare and maintain documentation in compliance with medical device regulations and support regulatory submissions. 

 

応募資格 

必須条件： 

• 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） 

 

歓迎条件： 

• 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 

 

Qualifications 

Required： 

• Experience in the design and development of medical devices 

• Familiarity with preparing development documentation in accordance with QMS 

• Knowledge of medical device regulations such as ISO 13485 and ISO 14971 

• Business-level English proficiency, including authoring documents and leading discussions in meetings 

Preferred： 

• Experience in designing and developing optical-related devices (e.g., endoscopes, optical fibers, laser systems) 

• Experience in manufacturing engineering, including process development and production control 

• Experience as a project leader or in project management roles 

 

 

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 

 

Desired Skills and Attributes： 

• A collaborative team player who can work effectively across departments 

• A logical thinker with strong problem-solving skills to address technical challenges 

• Curious and open-minded, with a passion for exploring new technologies 

• Deeply committed to understanding clinical needs and developing medical devices that balance safety and efficiency