ph3The Opportunity /h3pIn this role, you will engage in extensive cross‑functional collaboration, particularly with Quality Assurance (QA), Regulatory Affairs, Clinical, and Commercial teams. Additionally, you will take on strategic responsibilities and contribute to efforts led by the Device Engineering leadership team. /pulliAct as project leader / team leader / technical expert to successfully bring combination products and medical devices to the market. /liliEvaluation of new and breakthrough technologies. /liliApplication 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. /liliAuthor design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance). /liliConformity assessments and risk management documentation. /liliForecast and plan resource demands for device development projects. /liliExecute projects within the agreed time, quality and cost constraints, resulting in state‑of‑the‑art drug delivery devices. /liliApply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO13485,21CFR820,ISO14971 and21CFR820.30). /li /ulh3Who You Are /h3ulliYou have university‑level education (engineering degree or related discipline). /liliMinimum 10‑year proven track record in mechanical engineering and drug delivery device development in pharma or other closely‑regulated environments under cGxP, QSR, or similar practices. /liliHands‑on Pen injector / Auto injector development expertise. /liliSound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. /liliExperience with Health Authority interactions. /liliDemonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, and reliability engineering. /liliExcellent documentation, presentation, interpersonal communication skills and strategic thinking. /liliExcellent command of the English language; proficiency in German is preferable. /li /ulpRoche is an Equal Opportunity Employer. /p /p #J-18808-Ljbffr
