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
The Device Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.
The Device Engineering section combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.
The opportunity:
In this role you will have considerable cross-functional interaction, notably including QA, Regulatory Affairs, Clinical and Commercial functions. This role reports to the Section Head of Device Engineering and is integrated into the Roche Device Development function.
- Act as project leader / team leader / technical expert to successfully bring combination products and medical devices to the market
- Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product
- Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation.
- Forecast and plan resource demands for device development projects. Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices
- Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
Who you are:
- You have university level education (engineering degree or related discipline).
- You have a minimum 5-year proven track record in mechanical engineering and drug delivery device development with experience in pharma or other closely-regulated environments, under current Good Practice (cGxP), Quality System Regulation (QSR), or similar working practices.
- You have hands-on Pen injector / Auto injector development expertise.
- You have sound knowledge of legislation, regulation, industry standards, and guidance within the area of combination products and medical devices.
- You have experience with Health Authority interactions.
- You have demonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, reliability engineering, and problem solving.
- You possess excellent documentation, presentation, and interpersonal communication skills.
- You have an excellent command of the English language; proficiency in German is preferable.
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.
