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Device technology deployment manager

Basel
Roche
Inserat online seit: Veröffentlicht vor 10 Std.
Beschreibung

Ph3Device Technology Deployment Manager /h3pLead and execute end‑to‑end device and packaging technology deployment projects and sub‑projects within regulated manufacturing environments. /ph3Responsibilities /h3ulliDrive strategic equipment and process initiatives to enhance product robustness, efficiency, and future‑readiness, including the introduction of novel technologies across the entire product lifecycle. /liliOwn the technology lifecycle from concept assessment and pilot execution through to large‑scale deployment, rigorously evaluating feasibility, scalability, and implementation readiness. /liliProactively identify risks and implement effective mitigation strategies to ensure project objectives, scope, and timelines are achieved. /liliOversee and execute critical equipment acceptance protocols (FAT, SAT), coordinating user engagement and ensuring compliance with regulated standards. /liliEnsure timely review and approval of critical design, qualification, and validation deliverables (e.g., technical specifications, test documentation) in partnership with Site Engineering, Quality, Device Development, MSAT and User teams. /liliEnsure seamless, cross‑functional coordination and alignment among key project stakeholders, including Automation, Quality/Compliance, Process Engineering, and Manufacturing Operations. /liliManage the full supplier relationship lifecycle, including selection, contract engagement, performance monitoring, and comprehensive review of critical technical documentation. /li /ulh3Qualifications /h3ulliBachelor's (B.S.) or Master's (M.S.) degree in Engineering (e.g., Mechanical, Biomedical, Chemical), Science, or a closely related technical field. /lili7+ years of technical Project Management experience (e.g., CAPEX projects), specifically focused on the deployment, industrialization, and qualification of complex new equipment and technologies, including expertise in supplier management, URS, machine risk assessments, and C Q strategies. /liliExperience in a highly regulated environment (preferably Medical Device or Pharmaceutical manufacturing), a solid understanding of cGMP, ISO standards (e.g., ISO 13485), and FDA regulations (21 CFR Part 820), and deep knowledge of medical device manufacturing processes, with hands‑on experience in at least two of the following: Device Assembly, Final Sterilization Processes, or Final Packaging. /liliProven ability to lead and support process development and technology scaling from early feasibility studies through to New Product Introduction (NPI), including familiarity with Automation/MES systems (a significant advantage). /liliDemonstrate exceptional communication, negotiation, and influencing skills, be fluent in English, and have a willingness to travel internationally (up to 25%) to support equipment acceptance testing (FAT) and site implementation. (PMP or other recognized certification is highly desirable.) /li /ulh3Equal Opportunity Employer /h3pRoche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. /p /p #J-18808-Ljbffr

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