Seeking an experienced leader to drive the deployment of advanced device assembly and packaging technologies. Oversee complex projects from concept to industrial implementation, ensuring robust manufacturing solutions. Ideal for candidates with deep device manufacturing expertise and strong technical leadership in regulated environments.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
Tasks
- Lead end-to-end deployment of automated device assembly and packaging technologies, from concept assessment and equipment selection through design, FAT/SAT, commissioning, qualification, and manufacturing implementation.
- Translate product and process requirements into robust equipment concepts, technical specifications, and scalable manufacturing solutions for device assembly and packaging.
- Provide technical leadership for the development and deployment of automated and high-speed device assembly and packaging platforms.
- Drive strategic equipment and process technology initiatives to improve manufacturing robustness, efficiency, automation, and future readiness across the product lifecycle.
- Evaluate new assembly, packaging and robotic technologies through feasibility studies, pilots, and technical assessments to determine their readiness for industrial-scale deployment.
- Provide technical leadership during equipment design reviews, machine risk assessments, FAT/SAT, commissioning, qualification, and process validation.
- Ensure critical design, qualification, and validation deliverables are technically sound and aligned with product and process requirements, working closely with cross-functional teams.
- Lead technical collaboration with equipment suppliers, including supplier selection, technical clarification, design development, performance management, and review of critical technical documentation.
- Support the development and harmonization of global manufacturing technology standards and platform solutions for device assembly and packaging.
Requirements
- You are an experienced and technically strong leader who combines deep device manufacturing knowledge with the ability to lead complex technology deployment projects in a global, highly regulated environment.
- You are a collaborative team player with strong communication, negotiation, influencing, and stakeholder management skills across technical functions, manufacturing sites, and external suppliers.
- Bachelor's (B.S.) or Master's (M.S.) degree in Engineering, such as Mechanical Engineering, Automation, Biomedical Engineering, Process Engineering, or a related technical discipline.
- 7+ years of relevant experience in medical device, drug-device combination product, pharmaceutical, or similarly regulated manufacturing environments, including a solid understanding of cGMP, ISO 13485, and applicable FDA requirements.
- Strong hands-on experience with automated device assembly equipment and processes, preferably including drug-delivery devices such as autoinjectors or pen injectors.
- Demonstrated experience taking complex manufacturing equipment from concept and URS through design, FAT, SAT, commissioning, qualification, and production implementation.
- Ideally, experience with robotics and automated packaging technologies.
- Fluency in English.
- This role involves travel internationally up to approximately 25%, particularly for supplier activities, FATs, and site implementation.
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Über uns
Das Team
Our department drives the industrialization of innovative medical devices and combination products, acting as the vital link between development and commercial manufacturing to reliably deliver high-quality treatments to our patients.