Device Technology Deployment Manager

Roche•Hillsboro, OR

3d•Onsite

About The Position

At Roche, we foster a culture where individuality is embraced, and personal expression, open dialogue, and genuine connections are encouraged. We value, accept, and respect everyone for who they are, enabling them to thrive personally and professionally. This commitment drives our mission to prevent, stop, and cure diseases and ensure universal access to healthcare for present and future generations. Join Roche, where every voice matters. The PTT (MSAT & Engineering) department is tasked with keeping PT at the technological forefront of our facilities, supporting our robust processes and efficient operations. Our focus is on integrating product health, process health, and equipment suitability with facility readiness to support the manufacturing network. Global MSAT is responsible for seamless technical product health and lifecycle management, developing and deploying new technologies and network standards, systematically improving processes across the pharma portfolio, solving operational challenges with data-driven insights, and ensuring the sustainable scaling of innovations across the network. Device Manufacturing Engineering defines and drives the Pharma TechOps device manufacturing process characterization, development, and technology deployment. This ensures the robust, efficient, compliant, and cost-effective manufacturing of Roche's medical devices and drug-device combination products throughout their entire lifecycle, from initial design to continuous improvement.

Requirements

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).
Solid understanding of cGMP, ISO standards (e.g., ISO 13485), and FDA regulations (21 CFR Part 820).
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).
Demonstrate exceptional communication, negotiation, and influencing skills.
Fluent in English.
Willingness to travel internationally (up to 25%) to support equipment acceptance testing (FAT) and site implementation.

Nice To Haves

Familiarity with Automation/MES systems (a significant advantage).
PMP or other recognized certification is highly desirable.

Responsibilities

Lead and execute end-to-end device and packaging technology deployment projects and sub-projects within regulated manufacturing environments.
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.