Device Technology Deployment Manager

Device Technology Deployment Manager Genentech - 4.1 Hillsboro, OR Job Details Full-time 1 day ago Qualifications Vendor relationship building New product introduction engineering projects English GMP Project management in manufacturing Manufacturing facility Policy & process development Vendor relationship management Biomedical regulatory compliance Technical Proficiency Negotiation FDA regulations Full Job Description The Position PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network. Global MSAT ensures seamless technical product health and lifecycle management, develops and deploys new technologies and network standards, systematically improves processes across the pharma portfolio, solves operational challenges through data-driven insights and ensures sustainable scaling of innovations across the network. Device Manufacturing Engineering defines and drives the Pharma TechOps device manufacturing process characterization, development, and technology deployment, ensuring robust, efficient, compliant, and cost-effective manufacturing of Roche's medical devices and drug-device combination products across their entire life cycle, from early design through continuous improvement. The Opportunity As the Device Technology Deployment Manager, you lead and execute end-to-end device and packaging technology deployment projects and sub-projects within regulated manufacturing environments. Your role includes the following main responsibilities: Drive strategic equipment and process initiatives to enhance product robustness, efficiency, and future-readiness, including the introduction of novel technologies across the entire product lifecycle. Own the technology lifecycle from concept assessment and pilot execution through to large-scale deployment, rigorously evaluating feasibility, scalability, and implementation readiness Proactively identify risks and implement effective mitigation strategies to ensure project objectives, scope, and timelines are achieved. Oversee and execute critical equipment acceptance protocols (FAT, SAT), coordinating user engagement and ensuring compliance with regulated standards. Ensure 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. Ensure seamless, cross-functional coordination and alignment among key project stakeholders, including Automation, Quality/Compliance, Process Engineering, and Manufacturing Operations. Manage the full supplier relationship lifecycle, including selection, contract engagement, performance monitoring, and comprehensive review of critical technical documentation. Who you are We are seeking a highly experienced and technically proficient individual who is ready to lead complex technology deployment projects within a regulated environment. Bachelor's (B.S.) or Master's (M.S.) degree in Engineering (e.g., Mechanical, Biomedical, Chemical), Science, or a closely related technical field. 7+ 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. Experience in a highly regulated environment (preferably Medical Device or Pharmaceutical manufacturing), a solid understanding of c

GMP, 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. Proven 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). Demonstrate 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.) Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity! Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.