Senior Engineer Pen​/Autoinjector

Position

Roche’s Device Development department, part of Roche Technical Development, is responsible for designing, engineering, testing and manufacturing drug delivery devices that support our portfolio of products. The Device Engineering section focuses on developing reliable and safe devices that meet the needs of patients, healthcare providers and Health Authorities. In this role you will lead cross‑functional initiatives and contribute to strategic engineering efforts within the Device Engineering leadership team.

• Engage in extensive cross‑functional collaboration with Quality Assurance, Regulatory Affairs, Clinical and Commercial teams.
• Act as project leader, team leader or technical expert to successfully bring combination products and medical devices to market.
• Evaluate new and breakthrough technologies to determine feasibility for development.
• Apply theoretical engineering knowledge to establish robust technical product requirements and develop engineering design solutions that ensure device performance throughout its lifecycle.
• Author and maintain design control documentation, including Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and Device History File (DHF).
• Perform conformity assessments and risk‑management documentation in line with ISO
  13485, ISO
  14971, 21
  
  CFR
  820 and 21
  
  CFR
  820.30.
• Forecast and plan resource demands for device development projects.
• Execute projects within agreed time, quality and cost constraints, delivering state‑of‑the‑art drug delivery devices.

• University‑level education in engineering or a related discipline.
• Minimum 10years of proven experience in mechanical engineering and drug delivery device development in pharma or other closely regulated environments under cGxP, QSR or similar working practices.
• Hands‑on expertise in Pen injector/Auto injector development.
• Sound knowledge of legislation, regulation, industry standards and guidance for combination products and medical devices.
• Experience interacting with Health Authorities.
• Demonstrable knowledge of drug delivery devices, parenteral 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 English; proficiency in German is preferable.

Roche is an Equal Opportunity Employer.