Drive engineering excellence in the development and support of drug delivery devices by leading technical solutions for container closure systems and ensuring compliance with global standards. This role is ideal for experienced professionals in mechanical engineering and drug delivery device development within regulated environments.
Tasks
- Serve as technical lead and subject matter expert to bring combination products and medical devices from development to market.
- Apply deep expertise in primary container materials (Type I glass, COP/COC polymers, elastomers, functional coatings) and extractables/leachables (E&L) profiles to establish robust technical specifications for primary packaging systems.
- Develop and evaluate container closure design solutions to ensure seamless device integration, container integrity, fill/finish expertise, and sustained technical performance.
- 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 resolve design-related device and primary container issues (e.g., break-loose/glide force, glass damage mechanisms, sub-visible particles, stopper movement) by applying 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, 21 CFR Part 4, ISO 11040, ISO 11608, USP <1207> / USP <381> / USP <660>).
- Engage in extensive cross-functional collaboration, particularly with Quality Assurance, Regulatory Affairs, Clinical, and Commercial teams.
Requirements
- 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).
- Strong expertise in container closure systems, specifically prefilled syringes (PFS) and cartridges for parenteral drug delivery (including CCI testing, elastomer/coating chemistry, staked-needle integration, and dimensional stack-ups).
- Experience in fill / finish technology including stoppering.
- 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 (including Module 3 authoring for IND/IMPD and NDA/BLA).
- 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 for this global role; German proficiency is a plus.
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Über uns
Das Team
The Device Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. The team collaborates across engineering disciplines from requirements definition through commercialization and marketed product support, combining design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices. This role reports to the Section Head of Device Engineering and is integrated into the Roche Device Development function.