Senior Device Engineer with Pen- / Autoinjector expertise, Basel

Overview

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.Position

The Device Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. The Device Engineering section combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.Responsibilities

Act as project leader, team leader or technical expert to successfully bring combination products and medical devices to the market. Evaluate new and breakthrough technologies. Apply theoretical engineering knowledge to establish robust technical product requirements and develop engineering design solutions that assure devices maintain the required level of performance throughout the life of the product.Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans, and Device History File creation/maintenance), conformity assessments and risk management documentation. Forecast and plan resource demands for device development projects.Execute projects within the agreed time, quality and cost constraints, resulting in state‑of‑the‑art drug delivery devices. Apply knowledge of the regulatory landscape to ensure standard‑compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30). Qualifications

University‑level education (engineering degree or related discipline). Minimum 5‑year proven track record in mechanical engineering and drug delivery device development with experience in pharma or other closely‑regulated environments, under current Good Practice (cGxP), Quality System Regulation (QSR), or similar working practices.Hands‑on Pen injector / Auto injector development expertise. Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Experience with Health Authority interactions. Demonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, reliability engineering, and problem solving.Excellent documentation, presentation and interpersonal communication skills. Excellent command of the English language; proficiency in German is preferable. Company

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.Equal Opportunity Employer

Roche is an Equal Opportunity Employer.

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