全球研发注射器设计经理

Role Overview Oversee the design, development, testing, and troubleshooting of IOL products and their preloaded injector systems, ensuring technical excellence and regulatory compliance. Manage and mentoring a team of engineers, fostering a high-performance culture and supporting individual growth and development. Serve as the technical lead for multiple complex projects, driving innovation and execution across design, prototyping, and validation phases. Define and implement strategic direction for mechanical design activities, including drawing standards, material selection, and risk mitigation strategies. Facilitate cross-functional collaboration with Global R&D, Operations, Quality, Marketing, CRMA and external partners to ensure alignment and timely delivery. Drive continuous improvement in design processes, documentation quality, and team capabilities. Duties and Responsibilities As the manager of the Injector Design Team, this position is expected to perform the following duties on assigned projects: Lead the planning and execution of product design and development activities for projects approved by the Pipeline Governance Committee (PGC) and Feasibility Steering Committee (FSC). Manage the development of prototypes and mechanical components that meet the specifications of approved Product Requests/TPPs. Provide technical oversight and strategic guidance for complex engineering challenges, ensuring robust risk mitigation and design reliability. Coordinate execution plans with project managers and technical leads, including criteria, cost, and milestone alignment. Review and approving engineering outputs, including Mechanical design blueprints Mechanical test results Mechanical specifications and drawings Design verification and validation reports Engineering reports Ensure effective use and maintenance of R&D equipment. Lead team-wide initiatives for drawing standardization, process optimization, and knowledge sharing across global engineering functions. Manage resource allocation, performance reviews, and career development for team members. Support strategic research and innovation efforts in ophthalmic device design, particularly in the preloaded injector systems. Represent the team in cross-functional leadership forums and contributing to organizational strategy. Perform other duties as assigned by the head of Product Design Group, including leading strategic research initiatives and cross-unit collaborations to explore new concepts in ophthalmic device design—particularly in the preloaded injector systems including IOL. Authority Authority to review and approve technical deliverables related to injector design and development, including design specifications, drawings, test plans and results, risk management documents, and design verification and validation protocols/reports, in accordance with applicable procedures and the Quality Management System. Decision-making authority over resource allocation, work prioritization, technical assignments, and engineering decisions within the Injector Design Team, in alignment with approved project priorities and organizational objectives. Authority to represent the Injector Design Team in cross-functional technical and project reviews and provide technical direction and recommendations regarding injector development activities. Requirements Experience Minimum 10 years of industry experience in product design and development for medical devices, precision instruments, or electronic devices. Proven track record of leading complex technical projects and launching commercial products. Experience in the IOL industry is plus but not mandatory. Demonstrated success in managing engineering teams and mentoring talent. Strong background in cross-functional collaboration, including international teams and external research institutions. Skills/Accreditations Ability to inspire and guide teams, manage multiple priorities, and drive technical excellence. Advanced proficiency in 3D CAD-based product design and drawing standardization. Deep expertise in plastic materials, injection molding, and mechanical design principles. Strong command of FEA, FMEA, FTA, statistics, usability engineering, risk management, ophthalmology, and ISO standards for medical devices. Strategic understanding of global regulatory and design standards (US, EU, Japan). Excellent leadership, communication, and organizational skills in both English and Japanese. Academic Qualifications Bachelor’s degree in mechanical engineering or a related field in science or engineering. Master’s degree or PhD is preferred. Travel requirements Up to 20%, typically within Asia, but may need to travel to the USA or Europe. 【職種 / 募集ポジション】 Manager, Injector Design, Global R&D 【雇用形態】 正社員 【給与】 応相談 〜 【勤務地】 174-0041 東京都板橋区舟渡1-12-11 ヘリオスⅡ3F 会社情報 【会社名】 HOYA株式会社 【代表者】 池田 英一郎 【本社所在地】 東京都新宿区西新宿6-10-1 日土地西新宿ビル 20F 【設立】 1944年8月 【従業員数】 37,909名（連結） 【事業内容】 HOYA株式会社は、1941年に東京で創業し、ヘルスケアとテクノロジーの革新を牽引するグローバル企業です。メガネレンズ、眼内レンズ、医療用内視鏡などのライフケア製品に加え、今日の情報社会を支える高精度部品として、半導体製造用マスクブランクス、ハードディスク用ガラス基板、イメージング機器向け光学部品などを提供しています。世界150以上の拠点で約38,000名の従業員が、持続可能な未来の実現に貢献しています。