About the Role
The Device Engineering position is a hands‑on engineering role focused on developing and supporting drug delivery devices for the product portfolio at Roche Technical Development. This role drives engineering excellence by applying design controls, solving complex device challenges, and providing strategic technical guidance throughout the lifecycle of combination products and medical devices. You will serve as the Technical Project Lead or Subject Matter Expert, collaborating cross‑functionally with Quality Assurance, Device MSAT, Regulatory Affairs, Pharmaceutical Development, Clinical, and Commercial teams to ensure seamless advancement into clinical phases and the commercial market. Responsibilities
Lead technical investigations and 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 all product designs and processes comply with ISO 13485, ISO 14971, and 21 CFR Part820 (with an emphasis on 820.30 Design Controls). Collaborate with external partners to provide technical oversight on mechanical designs for combination products, ensuring high performance, design robustness, and fostering innovation. Apply deep engineering expertise to establish robust technical product requirements and develop drug‑device combination product design solutions that maintain required performance throughout the full product lifecycle. Provide strategic technical guidance and support to cross‑functional teams during product development, commercialization, and marketed product support. Qualifications
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, including 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. Excellent communication skills, strategic thinking, and strong documentation/presentation capabilities to influence stakeholders. Fluency in English is required; German proficiency is a plus. Roche is an Equal Opportunity Employer.
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The Device Engineering position is a hands‑on engineering role focused on developing and supporting drug delivery devices for the product portfolio at Roche Technical Development. This role drives engineering excellence by applying design controls, solving complex device challenges, and providing strategic technical guidance throughout the lifecycle of combination products and medical devices. You will serve as the Technical Project Lead or Subject Matter Expert, collaborating cross‑functionally with Quality Assurance, Device MSAT, Regulatory Affairs, Pharmaceutical Development, Clinical, and Commercial teams to ensure seamless advancement into clinical phases and the commercial market. Responsibilities
Lead technical investigations and 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 all product designs and processes comply with ISO 13485, ISO 14971, and 21 CFR Part820 (with an emphasis on 820.30 Design Controls). Collaborate with external partners to provide technical oversight on mechanical designs for combination products, ensuring high performance, design robustness, and fostering innovation. Apply deep engineering expertise to establish robust technical product requirements and develop drug‑device combination product design solutions that maintain required performance throughout the full product lifecycle. Provide strategic technical guidance and support to cross‑functional teams during product development, commercialization, and marketed product support. Qualifications
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, including 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. Excellent communication skills, strategic thinking, and strong documentation/presentation capabilities to influence stakeholders. Fluency in English is required; German proficiency is a plus. Roche is an Equal Opportunity Employer.
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Principal Device Engineer Arbeitgeber: F. Hoffmann-La Roche AG
F. Hoffmann-La Roche AG bietet eine herausragende Arbeitsumgebung in Basel, die von Innovation und Zusammenarbeit geprägt ist. Als Arbeitgeber im biopharmazeutischen Sektor fördern wir das Wachstum unserer Mitarbeiter durch kontinuierliche Weiterbildung und Entwicklungsmöglichkeiten. Unsere Unternehmenskultur legt Wert auf Vielfalt und Teamarbeit, was es zu einem idealen Ort macht, um bedeutende Beiträge zur Zukunft der Gesundheitsversorgung zu leisten.
