Status: Full-time
Department: Device R&D
Position Summary
医療機器の設計開発において、設計開発を信頼性工学の観点で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、製造委託業者への設計移管をリードし、工程設計にも幅広く関与していただきます。また、市場で発生した不具合の分析と設計開発へのフィードバックを通じて製品の信頼性向上にリードします。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。
We are seeking engineers capable of leading design and development from a reliability engineering perspective for medical devices. In addition to technical expertise in design and verification, you will lead the design transfer to manufacturing contractors and be extensively involved in process design. Furthermore, you will drive improvements in product reliability by analyzing complained products in the market and feeding the findings back into design and development. We expect you to deliver innovative medical devices to the market with a broad perspective, combining both technical expertise and project management skills.
Responsibilities
- 医療機器品質管理システムに必要なプロセス文書（特に設計・開発分野）の作成、レビュー、維持管理
- グローバルな多職種チームと連携し、ユーザー/製品要件、リスク分析、検証・妥当性確認などを推進
- 品質管理システムおよび医療機器に関連する現行の規制、規格、ガイダンスに関する実務知識の維持
- 医療機器に対する信頼性試験の実施。信頼性試験には、ストレステスト、保存期間試験、輸送試験、必要に応じて環境試験が含まれる
- 医療機器に対する製品の設計検証試験の実施
- 医療機器開発の設計管理において、設計移管の実施
- 苦情・不具合製品の分析調査
- Write, review, and maintain documentation of processes required for Rakuten Medical’s device quality management system, especially in Design & Development
- Work closely with a global multidisciplinary team to oversee user/product requirement, risk analysis, verification & validation, etc.
- Maintain working knowledge of current regulations, standards, and guidance related to quality management systems and medical devices.
- Perform reliability testing for Rakuten Medical’s medical devices. Reliability tests include stress test, shelf-life test, shipping test and environmental test if necessary.
- Perform hands-on product testing for Rakuten Medical’s medical devices.
- Perform design transfer activities in design control of medical device development.
- Analysis and investigation of Complaints and defective products.
Qualifications
Required：
- 理学、工学、または関連分野の学士号以上を有すること
- 関連する医療機器業界における2年以上の実務経験と知識を有すること。より豊富な経験を有する候補者は上級職として考慮される
- 医療機器エンジニアリングスキル（設計・開発、技術文書作成、製品取り扱い、根本原因分析、データ分析、リスク管理）
- ISO 13485および厚生労働省告示第169号に関する深い知識を有すること
- ISO 14971及びISO, IECなどの規制規格に関する深い知識を有すること
- 生産技術（製造プロセス、工程管理）の経験を有すること
- 優れた口頭・文書によるコミュニケーション能力、および日本語の読解・作成・会話能力を有すること
- 基本的な英語文書の読解力・記述力・理解能力、および会話によるコミュニケーション能力を有すること
- A minimum of a bachelor’s degree in science, engineering, or a related field. At least 2+ years of experience and knowledge of relevant medical device industry. Candidates with more experience will be considered for a senior position
- Medical device engineering skills (design & development, technical documentation, product handling, root cause analysis, analysis of data, and risk management)
- Thorough knowledge is expected of ISO 13485 and MHLW MO 169.
- Thorough knowledge of regulatory standards such as ISO 14971, ISO and IEC.
- Experience in production technologies (manufacturing processes, process control)
- Excellent verbal and written communication skills and ability to read, write, and speak
- Ability of basic reading comprehension, writing and understanding skills of English documents, as well as conversational communication skills.
Preferred：
- 社内関係者との優れた英語でのコミュニケーション経験、および英語の読解力・記述力・理解能力を有することが強く望ましい
- 医療機器開発における信頼性試験および設計移管の実務経験
- Experience in excellent communicating in English with internal stakeholders and ability of reading comprehension, writing and understand is strongly preferred.
- Hands-on experience with reliability testing and design transfer in medical device development.
Desired Skills and Attributes
- 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
- Strong teamwork and collaboration skills with other departments
- Logical problem-solving abilities for technical challenges
- A passion for exploring new technologies and innovative thinking
- Understanding of medical field needs with a commitment to safety and efficiency in product development
Top Skills
What We Do
Rakuten Medical, Inc. is a global clinical stage biotechnology company developing and commercializing precision, cell-targeting investigational therapies on its AlluminoxTM platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Alluminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first drug developed on the Alluminox platform, ASP-1929, has received approval from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. The company has locations in 5 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, and Switzerland. For more information, visit www.rakuten-med.com.
