Medical Device Platform Technical Lead

Roche•South San Francisco, CA

About The Position

Pharma Technical Operations (PT) is responsible for manufacturing, supply chain, and quality across the pharmaceutical network. Within PT, 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 Device, Packaging and Distribution MSAT ensures our device-related products including platforms and packaging systems are robustly engineered, efficiently manufactured, and safely delivered and maintained. The medical device platform team at Roche advances innovative drug delivery systems supporting Roche’s therapeutic, eye care and incretin portfolios. We are seeking a highly skilled Medical Device Platform Technical Lead to lead and contribute to the development and maintenance of Autoinjector, and/or PFS-Needle Safety Device platforms utilized in drug-device combination products. In this senior level role, you lead a cross functional technical team to develop and maintain robust drug delivery platforms utilized within both the development and commercial lifecycles. This role demands a high level of expertise in systems engineering fundamentals, mechanical product and process design as well as collaborative operation within a cross functional matrix team environment. The Opportunity The Medical Device Platform Technical Lead is a senior level individual contributor role within the Global Device Platform and Lifecycle Engineering team, responsible for driving design excellence across a diverse range of device platform technologies. Lead Platform Technology teams in the creation and maintenance of the Platform Design History File (DHF) for use across the development and commercial lifecycles including collaborating with development and sustaining lifecycle product/molecule teams and CDMOs/CMOs to develop/maintain the platform based DHF elements and all required Platform DHF documents Lead platform initiatives in supporting product design and development teams operating across the development and commercial lifecycles to strategically plan and implement platform data leverage plans and provide platform technical support for E2E project activities. Work with global cross-functional teams to broaden the understanding and implementation of product and platform development principles within established processes Your collaboration extends beyond internal partners to external organizations and potential partners as well. The external activities require you to develop and foster relationships with third-party development partners globally. Provide technical expertise in various systems engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management, and reliability for platform devices. Develop, harmonize, and streamline phase-appropriate platform-based verification and testing methodologies across Roche’s delivery device portfolio. Collaborate closely with regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing technical documentation for regulatory submissions and audits for platform-based attributes as well as with development and sustaining engineering team leaders to manage CDMO relationships related to platform focused design activities for device platforms. Who you are The ideal candidate will bring a systems-level perspective, integrating device constituents and container closure systems for device platforms, ensuring compliance with regulatory and quality standards bridging engineering disciplines to deliver safe, effective and scalable drug delivery device solutions that can serve both functional and industrialization requirements.

Requirements

BS in Mechanical Engineering or equivalent technical degree with 10+ years experience including in-depth understanding of prefilled syringes, Autoinjector, PFS-Needle Safety Device and/or novel drug delivery design and manufacturing processes
Technical expertise in device and integrated combination product development, including comprehensive understanding of pharmaceutical and delivery system processes and with Medical Device regulations
Experience with Requirement Management including Requirement Hierarchies, Traceability, Authorship, Platform vs Variant modalities, and with systems engineering fundamentals including continuous improvement methods and toolsets
Excellent communication, interpersonal, and collaboration skills to effectively engage with cross-functional teams, external suppliers, and industry partners with the ability to influence across scientific disciplines and organizational boundaries.
Entrepreneurial spirit with a hands-on, roll-up-your-sleeves approach and high sense of urgency and dedication to drive for results.

Responsibilities

Lead Platform Technology teams in the creation and maintenance of the Platform Design History File (DHF) for use across the development and commercial lifecycles including collaborating with development and sustaining lifecycle product/molecule teams and CDMOs/CMOs to develop/maintain the platform based DHF elements and all required Platform DHF documents
Lead platform initiatives in supporting product design and development teams operating across the development and commercial lifecycles to strategically plan and implement platform data leverage plans and provide platform technical support for E2E project activities.
Work with global cross-functional teams to broaden the understanding and implementation of product and platform development principles within established processes
Provide technical expertise in various systems engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management, and reliability for platform devices.
Develop, harmonize, and streamline phase-appropriate platform-based verification and testing methodologies across Roche’s delivery device portfolio.
Collaborate closely with regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing technical documentation for regulatory submissions and audits for platform-based attributes as well as with development and sustaining engineering team leaders to manage CDMO relationships related to platform focused design activities for device platforms.

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