Senior Engineer with Pen- / Autoinjector

Poste

Temps plein

Senior

Ingénierie

Modalités

Basel

Clôture dans 30 jours

Exigences

10+ ans d'exp.

Bachelor

Permis UE/AELE

Compétences

21 CFR 820Statistical techniquesReliability engineeringISO 13485Risk ManagementGxP complianceDesign controlsMedical device developmentEngineering degreeAutoinjector DesignCapability buildingRegulatory frameworks

Langues

Anglais C2

Allemand

Description

The 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.

Responsabilités

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)

Exigences

You have university level education (engineering degree or related discipline).
You have a minimum 10-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 reliability engineering.
You possess excellent documentation, presentation, interpersonal communication skills and strategic thinking.
You have an excellent command of the English language; proficiency in German is preferable.

Avantages

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.

Entreprise

Roche

Pharmaceuticals

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.