Device Engineer
vor 2 Wochen
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.
Roche is recruiting for a (senior) Device Engineer to support the development and maintenance of drug delivery devices (Prefilled Syringes with Needle Safety Devices, Autoinjectors, high-volume Patch-injectors).
The Device Engineering group performs combined design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers, and Health Authorities.
This role will require considerable cross-functional interaction, notably including QA, Regulatory Affairs, Clinical, and Commercial functions. The Device Engineer will report to the Section Head of Device Engineering and will be integrated into the Roche Device Development function.
As a Device Engineer, your primary responsibilities include:
- Act as project leader 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), conformity assessments, and risk management documentation.
- Execute projects within the agreed time, quality, and cost constraints, resulting in state-of-the-art drug delivery devices.
- Apply your knowledge of the regulatory landscape to ensure standard compliant designs ISO 13485, 21CFR820, ISO14971.
As a Device Engineer, you will bring the following qualifications and experience:
- University level education (engineering degree or related discipline) and minimum 5 years proven track record in mechanical engineering and drug delivery device development with experience of working in pharma or other closely-regulated environment, under current Good Practice (cGxP), Quality System Regulation (QSR) or similar working practices.
- 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 the following: drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, and transport studies and validation.
- Excellent documentation, presentation, and interpersonal communication skills with an excellent command of the English language and proficiency in German preferable.
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