Principal Device Engineer Pen​/Autoinjector expertise

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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.

In this role, you will engage in extensive cross-functional collaboration, particularly with Quality Assurance (QA), Regulatory Affairs, Clinical, and Commercial teams. Additionally, you will take on strategic responsibilities and contribute to efforts led by the Device Engineering leadership team. 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, 21
  
  CFR
  820, ISO
  14971 and 21 CFR 820.30)

• You have university level education (engineering degree or related discipline).
• You have a minimum 10-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, and reliability engineering.
• You possess excellent documentation, presentation, interpersonal communication skills and strategic thinking.
• You have an excellent command of the English language; proficiency in German is preferable.

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l’accès aux soins de santé aujourd’hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique.

Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

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