Switzerland, Basel-City, Basel Headquarter
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The Device Engineering group performs combine 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 role will require considerable cross-functional interaction, notably including QA, Regulatory Affairs, Clinical and Commercial functions. This role will report to the Section Head of Device Engineering and will be integrated into the Roche Device Development function. The primary responsibilities of this role are:
• Apply your knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, 21CFR820, risk management to ISO14971 and design control to 21 CFR 820.30,
• Author technical specifications, 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,
• 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,
• 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.
Qualifications:
• University level education (engineering degree or related discipline) and minimum 5 year 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, pharmacopeia testing, statistical techniques, process capability, manufacturing processes and transport studies and validation,
• Excellent documentation, presentation and interpersonal communication skills with an excellent command of English language and proficiency in German preferable.
Get in touch with the Recruiting Team Switzerland +41 61 682 25 50.
Roche is an equal opportunity employer.
Technical Development, Technical Development > Medical Device Technology Development