Principal Device Engineer Pen​/Autoinjector expertise

The Opportunity

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.

• 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).
• 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,.30).

• You have university‑level education (engineering degree or related discipline).
• Minimum 10‑year proven track record in mechanical engineering and drug delivery device development in pharma or other closely‑regulated environments under cGxP, QSR, or similar practices.
• Hands‑on Pen injector / Auto injector development expertise.
• Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices.
• Experience with Health Authority interactions.
• Demonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, and reliability engineering.
• Excellent documentation, presentation, interpersonal communication skills and strategic thinking.
• Excellent command of the English language; proficiency in German is preferable.

Roche is an Equal Opportunity Employer.