Exciting opportunity to drive engineering excellence in drug delivery device development by leading technical solutions, collaborating with cross-functional teams, and ensuring compliance with global standards. Ideal for experienced professionals in mechanical engineering and drug delivery within regulated environments.
Tasks
- Drive engineering excellence by applying design controls and solving complex device engineering challenges.
- Provide strategic technical guidance to ensure robust product development and compliance.
- Engage in cross-functional collaboration with Quality Assurance, Device MSAT, Regulatory Affairs, Pharmaceutical Development, Clinical, and Commercial teams.
- Serve as Technical Project Lead or Subject Matter Expert to drive robust development of combination products and medical devices.
- Ensure seamless advancement into clinical phases and commercial market applications.
- Apply deep engineering expertise and strategic insights to establish robust technical product requirements and develop drug-device combination product design solutions.
- Collaborate with external partners, providing technical oversight on mechanical designs for combination products.
- Lead internal and external technical investigations to resolve complex, design-related issues using structured problem-solving methodologies.
- Author and manage comprehensive design control documentation, including Design Development Plans, User Requirements Specifications (URS), Design Inputs/Outputs, Verification/Validation Plans, conformity assessments, and risk management files.
- Navigate the global regulatory landscape to ensure product designs and processes comply with industry standards, specifically ISO 13485, ISO 14971, and 21 CFR Part 820 (with emphasis on 820.30 Design Controls).
Requirements
- University degree (BSc or MSc) in engineering or a related technical discipline from an accredited institution.
- 10+ 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.
Benefits
At Roche you can show up as yourself, embraced for the unique qualities you bring. The culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected, allowing you to thrive both personally and professionally.
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Über uns
Das Team
Global Technical Development (PTD) is an organization of over two thousand people globally, integral to Roche's mission to develop meaningful medicines for patients. The Device Development department is responsible for the development and support of drug delivery devices for the product portfolio, spanning engineering disciplines from requirements definition through commercialization and marketed product support.