Device Process Engineer

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. Join Roche, where every voice matters. The Position The Global MSAT & Engineering (PTT) function is undergoing a massive, multi-site modernization initiative. We are taking bold steps to introduce innovative, efficient, and sustainable equipment and technology across our global device manufacturing landscape. As a Senior Process Engineer, you are the driving force behind the implementation of next-generation processes. The opportunity This critical role requires deep technical insight into device manufacturing—including assembly, sterilization, and packaging—to ensure robust, future-ready workflows and the reliable, compliant distribution of our products across the entire lifecycle. Design Transfer & Industrialization: - Lead design transfer of medical devices and drug-device combination products (e.g., autoinjectors, pens, needle safety devices) from development into internal and external manufacturing sites. - Ensure seamless scalability by bridging the gap between development and commercial-scale production. Process Engineering & Optimization: - Process Development & Characterization: Utilize Design of Experiments (DoE) to identify and evaluate Critical Process Parameters (CPPs), ensuring a deep understanding of how process variances impact product performance. - Drive DFx Excellence: Conduct Design for Manufacturability, Assembly, and Excellence (DFM/DFA/DFx) assessments to optimize assembly, sterilization, and packaging operations. - Advanced Technology Integration: Leverage state-of-the-art manufacturing technologies to develop robust processes for both clinical and commercial production. Quality, Validation & Risk Management: - Strategy Development: Define Process Performance Qualification (PPQ) and Quality Control strategies. - Risk Mitigation: Author and manage risk documentation, utilizing FMEA (Failure Mode and Effects Analysis) and Tolerance Analysis to ensure high process capability Continuous Improvement & Investigation: - Root Cause Analysis: Lead technical investigations into process deviations or design issues using structured methodologies. - Sustaining Engineering: Provide technical oversight for existing products, recommending process enhancements for sterilization, labeling, and packaging to maintain optimal performance. Who you are You have a B.S. or M.S. in Mechanical, Biomedical, Pharmaceutical Engineering, or a related technical discipline, you have worked in the pharmaceutical industry and you bring the following qualification: - 7+ years of experience in process engineering, specifically within medical device or drug-device combination product development and industrialization with proven track record with complex delivery systems, such as pre-filled syringes, needle safety devices, and autoinjectors/pen injectors. - Hands-on expertise in Device Assembly, Final Sterilization, or Final Packaging/Labeling. - Demonstrated ability to lead technology scaling and New Product Introduction (NPI), moving seamlessly from early-stage feasibility through to commercial-scale manufacturing. - Advanced proficiency in statistical data analysis, Quality by Design (QbD), and risk management tools, with a focus on developing comprehensive FMEAs, and solid command of cGMP, ISO 13485, and FDA 21 CFR Part 4/Part 820 regulations. - Exceptional communication and negotiation skills, with the ability to influence cross-functional stakeholders in a matrixed environment, with fluent English (ability to travel internationally -approx. 10-20%- to support Factory Acceptance Testing (FAT) and on-site implementation at manufacturing facilities) Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.