Job Description: (Senior) Device Engineer at Roche
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 such as Prefilled Syringes with Needle Safety Devices, Autoinjectors, and 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.
Primary Responsibilities:
1. Act as project leader to successfully bring combination products and medical devices to the market.
2. Evaluate new and breakthrough technologies. Apply theoretical engineering knowledge to establish robust technical product requirements and develop engineering design solutions to ensure devices maintain the required level of performance throughout their lifecycle.
3. Author design control documentation including Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans, and maintain the Design History File (DHF). Conduct conformity assessments and risk management documentation.
4. Execute projects within the agreed time, quality, and cost constraints, resulting in state-of-the-art drug delivery devices.
5. Apply knowledge of the regulatory landscape to ensure standard-compliant designs according to ISO 13485, 21 CFR 820, ISO 14971, and other relevant standards.
Qualifications and Experience:
1. University-level education (engineering degree or related discipline) and a minimum of 5 years proven experience in mechanical engineering and drug delivery device development, preferably within pharma or a closely-regulated environment, under current Good Practice (cGxP), Quality System Regulation (QSR), or similar practices.
2. Sound knowledge of legislation, regulation, industry standards, and guidance related to combination products and medical devices. Experience with Health Authority interactions.
3. Demonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, transport studies, and validation.
4. Excellent documentation, presentation, and interpersonal communication skills, with proficiency in English and preferably in German.
#J-18808-Ljbffr