Overview
In this role, you drive engineering excellence in Roche’s Device Development domain by leading design, testing, and risk-driven development of drug delivery devices. You collaborate across Quality, Regulatory, Clinical, and Commercial teams to bring combination products to market while ensuring compliance and robust performance. You will evaluate new technologies, guide external partners, and own technical investigations to swiftly resolve device issues. This position offers impact on patient access to safer, reliable delivery devices in a global, cross-functional setting.
Verantwortungsbereiche
- Act as technical project leader or expert to bring combination products and medical devices to market
- Evaluate new and breakthrough technologies to define robust product requirements and designs
- Collaborate with external partners for mechanical design oversight of combination products
- Lead internal and external technical investigations and apply structured problem solving
- Author design control documentation (Design Development Plans, User Requirements, Design Inputs/Outputs, Verification Plans) and risk management materials
- Apply regulatory knowledge to ensure designs meet standards (ISO 13485, 21CFR820, ISO14971)
Zentrale Anforderungen
- 5+ years in mechanical engineering and drug delivery device development in pharma or highly regulated environments (cGxP, QSR)
- Hands-on experience in pen injector and autoinjector development across product lifecycle
- Strong background in container closure systems (prefilled syringes and cartridges) for parenteral delivery
- Proven technical leadership and cross-functional collaboration
- Materials science expertise as applied to drug delivery systems, including damage mechanisms and performance testing
- Deep knowledge of global regulations and guidance for combination products and medical devices
- Experience navigating Health Authority interactions and regulatory submissions
- Technical proficiency in parenteral delivery, risk assessment, tolerance analysis, statistics, process capability, and reliability engineering
- Excellent communication, strategic thinking, and documentation/presentation skills
- Fluency in English; German proficiency is a plus
- Strong communication
- Strategic thinking
- Cross-functional collaboration
- Pen injector development
- Autoinjector development
- Parenteral drug delivery
Senior Container Closure Expert (PFS / Cartridges) in Basel Arbeitgeber: Roche
Roche ist ein hervorragender Arbeitgeber, der eine inklusive und respektvolle Arbeitskultur fördert, in der jeder Mitarbeiter geschätzt wird. Als Biostatistiker (m/w/d) in der Forschung und Entwicklung hast du die Möglichkeit, in einem interdisziplinären Team an innovativen Lösungen zu arbeiten und deine Fähigkeiten kontinuierlich weiterzuentwickeln. Zudem bietet Roche zahlreiche Möglichkeiten zur beruflichen Entfaltung und unterstützt aktiv die persönliche Entwicklung seiner Mitarbeiter.
