Senior Device Engineer

Overview

Device Engineering 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. This hands‑on role drives engineering excellence by applying design controls, solving complex device engineering challenges, and providing strategic technical guidance to ensure robust product development and compliance.

• Act as technical project leader or technical expert to successfully bring combination products and medical devices to market.
• Evaluate new and breakthrough technologies.
• Apply theoretical engineering knowledge to establish robust technical product requirements and develop engineering design solutions to assure device performance throughout the product life.
• Collaborate with external partners providing technical oversight on mechanical designs for combination products to ensure high performance, design robustness, and innovation.
• Lead internal and external technical investigations, swiftly resolving design‑related device issues using structured problem‑solving methodologies.
• Author design control documentation (e.g., Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans), conformity assessments, and risk management documentation.
• Apply knowledge of the regulatory landscape to ensure standard‑compliant designs (e.g., ISO
  13485, 21
  
  CFR
  820, ISO
  14971, 21
  
  CFR
  820.30).

• University degree (BSc or MSc) in engineering or a related technical discipline from an accredited institution.
• 5+ years of experience in mechanical engineering and drug delivery device development within pharma or highly regulated environments (cGxP, QSR).
• Hands‑on expertise in pen injector and autoinjector development throughout the entire product lifecycle.
• Strong background in container closure systems, specifically prefilled syringes and cartridges for parenteral drug delivery.
• Proven technical leadership and advanced problem‑solving capabilities in cross‑functional team environments.
• Solid understanding of materials science applied to drug delivery systems, with expertise in damage mechanisms, defect identification, and performance testing.
• Deep knowledge of regulations, industry standards, and guidance for combination products and medical devices on a global scale.
• Direct experience navigating Health Authority interactions and managing regulatory submissions.
• Technical proficiency in parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, and reliability engineering to resolve complex issues.
• Excellent communication skills, strategic thinking, and strong documentation/presentation capabilities to effectively influence stakeholders.
• Fluency in English is required. German proficiency is a plus.

Roche is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status or characteristic. Roche is also a veteran's preferred employer, providing equal opportunity for veterans to fill an official, competitive, interviewable, career position.