Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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 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 Opportunity
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 lifecycles.
- 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.
Who you are
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, MiniTab) and proficiency with SolidWorks or other 3D CAD (Computer Aided Design) modeling software.
- Proven track record of successful technical leadership and problem-solving in a regulated environment with excellent communication, interpersonal, and collaboration skills to effectively engage with cross-functional teams, external suppliers, and industry partners.
- Entrepreneurial spirit with a hands-on, roll-up-your-sleeves approach and high sense of urgency and dedication to drive for results.
Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
