(Senior) Device Engineer with Pen- / Autoinjector expertise

F. Hoffmann-La Roche Gruppe; Basel; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading company in the healthcare industry seeks a Senior Device Engineer with Pen- / Autoinjector expertise to support drug delivery device development. This role involves cross-functional collaboration and significant responsibility in device design and project management within a regulated environment.

Qualifikationen

• 5+ years in mechanical engineering and drug delivery device development.
• Hands-on Pen injector / Auto injector development expertise.
• Knowledge of ISO 13485, 21CFR820 regulations.

Aufgaben

• Lead projects to bring combination products and medical devices to market.
• Create and maintain design control documentation.
• Ensure designs are standard compliant with relevant regulations.

Kenntnisse

Project leadership

Mechanical engineering

Documentation

Interpersonal communication

Ausbildung

Engineering degree or related discipline

Tools

Application lifecycle software

Jobbeschreibung

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

(Senior) Device Engineer with Pen- / Autoinjector expertise

The Device & Packaging 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 Engineeringgroup 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.

The opportunity:

In this role you will have considerable cross-functional interaction, notably including QA, Regulatory Affairs, Clinical and Commercial functions. This role reports to the Section Head of Device Engineering and is integrated into the Roche Device & Packaging Development function.

• Act as project leader / team leader / technical expert to successfully bring combination products and medical devices to the market
• Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to 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 DHF creation/maintenance DHF), 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)

Who you are:

• You have university level education (engineering degree or related discipline).
• You have a 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.
• You have hands-on Pen injector / Auto injector development expertise.
• You have sound knowledge of legislation, regulation, industry standards, and guidance within the area of combination products and medical devices.
• You have experience with Health Authority interactions.
• You have demonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, and application lifecycle software.
• You possess excellent documentation, presentation, and interpersonal communication skills.
• You have an excellent command of the English language; proficiency in German is preferable.

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.