Designs and improves Global IT performance management, defines KPIs, monitors results, reports to leaders, identifies gaps, and supports efficiency, goal-setting, and budget activities.
About this role
Within Olympus’s R&D organization, this role owns the global product design and development process and supports the Global Process Owner. It works across regional design-control teams and functions such as quality, regulatory and medical program management to align regional and global procedures and move toward integrated product and process development.
The work standardizes Design Controls, including development planning, inputs and outputs, verification and validation, reviews, files and changes. Technology Readiness Levels and Systems Engineering are introduced, while the process is aligned with a next-generation PLM system, global rules are maintained and a global RACI is established. Required qualifications include a bachelor’s degree in Life Sciences or Engineering, QA or R&D experience in the medical-device, pharmaceutical or life-science industry, and experience developing and commercializing regulated devices under Design Control with knowledge of applicable regulations. Project-management ability and international process-improvement workshop experience are also required.
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