You lead projects and assess technologies while ensuring compliance with regulations. Your role includes creating documentation and forecasting resources for the development of innovative drug delivery devices.
Anforderungen
- •University level education in engineering
- •Minimum 5 years in mechanical engineering
- •Hands-on Pen injector development expertise
- •Sound knowledge of legislation and regulation
- •Experience with Health Authority interactions
- •Demonstrable knowledge of drug delivery devices
- •Excellent documentation and presentation skills
- •Excellent command of English; German is preferable
Deine Aufgaben
- •Lead projects and teams for product launch.
- •Evaluate new technologies and apply engineering knowledge.
- •Create and maintain design control documentation.
- •Forecast resource needs for development projects.
- •Ensure designs comply with regulatory standards.
Original Beschreibung
# (Senior) Device Engineer with Pen- / Autoinjector expertise
**Basel** | **Full time**
### 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 Engineering group 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.
**Roche is an Equal Opportunity Employer.**