Medical Device Platform Design Engineer

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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 Design Engineer to contribute to the design and maintenance of Autoinjector and/or PFS-Needle Safety Device platforms utilized in drug-device combination products.

The successful candidate is a hands-on problem solver, a strategic thinker, and a trusted technical advisor who can both dive deep into engineering challenges and provide actionable guidance and feedback across Roche’s development and sustaining engineering life cycles.

• Act as technical product design expert supporting product development and sustaining engineering teams throughout the platform-based combination product lifecycle.

• Provide professional mechanical engineering design expertise on multiple products, from concept generation and engineering analysis to both internally and externally utilized device design platform technologies.

• Interface with external suppliers and partners to provide technical oversight on the mechanical design of components and subassemblies used in combination products (prefilled syringes and autoinjectors), driving performance, accountability, and innovation.

• Lead reliability engineering assessments including edge-of-failure testing, variance management activities, tolerance sensitivity assessments, and creation/maintenance of Computer Aided Engineering models and digital twins for virtual analytical data collection.

• Actively seek out, anticipate, and solve significant functional and assembly related technical challenges of platform based Autoinjector and PFS-NSD combination products.

• Lead technical investigations, both within Roche as well as at third party manufacturers, for technical challenges related to design, manufacturing, and scale-up processes, to resolve device and assembly issues timely and effectively.

• Lead and participate in writing product and customer requirements, design and design phase reviews, product and process risk assessments, root cause investigations, and corrective action planning.

This role is ideal for a versatile, self-motivated engineer with a broad technical design foundation and the ability to adapt quickly across disciplines, projects, and challenges.

• BS in Mechanical Engineering or equivalent technical degree with experience including in-depth understanding of prefilled syringes, Autoinjector, PFS-Needle Safety Device and/or novel drug delivery design and manufacturing processes

• Familiarity with materials science, particularly as it relates to drug delivery systems, including knowledge of damage mechanisms, common defects, and performance testing.

• Working knowledge of system modeling tools and methodologies (Digital Twins, CAE, FEA, Mini Tab) and proficiency with Solid Works or other 3D CAD (Computer Aided Design) modeling software.

• Proven…