Medical Device Platform Technical Lead

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 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. 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 life cycles.

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.

• Lead Platform Technology teams in the creation and maintenance of the Platform Design History File (DHF) for use across the development and commercial life cycles, 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 life cycles to strategically plan and implement platform data leverage plans and provide platform technical support for end‑to‑end 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 managing CDMO relationships related to platform‑focused design activities for device platforms.

The ideal candidate will bring a systems‑level perspective, integrating device constituents 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.

• BS in Mechanical Engineering or equivalent technical degree with 10+ years experience including in-depth understanding of surgical implants, 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.

• Excel…