Medical Device Engineer - Product Care (80% - 100%)

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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. Roche is recruiting for a Principal Device Engineer to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices, Autoinjectors, high-volume Patch-injectors, oral delivery devices).The primary responsibilities as a member of the Product Care teamSupports, coordinates and drive resolution of unexpected product and manufacturing events, when there is a device or combination product manufacturing challenge (Production Issues, Deviations, Qualifications, Know How Transfers).Acts as a commercial complaint investigation support, evaluates the annual complaint analysis and supports follow up activities, for example, Root Cause Investigations, subsequent Corrective Action and Preventative Actions (CAPA) and Changes (Technical Change Management, Transfers, Capacity Expansion).Supports or leads technical Changes e.g. Design changes, Introduction of new therapeutic indications, establishing of additional suppliers, Vendor Initiated ChangeManage the Product Care Annual Review (PCAR)Ensuring regulatory compliance and Roche internal GMP standards (e.g. departmental archiving concept, records management and training)Interpret Pharma Quality System requirements into local operational processesSupport internal/external Quality/Regulatory/SGU inspections(Re-) Present PTDE-D in Project Teams, Quality Boards and Governance Bodies, as needed providing Subject Matter Expert (SME) expertiseContinuous optimization of performance and striving for excellenceWho you are:You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies; where a job title is not considered the final definition of who you are, but the starting point.Additionally to that, we are looking for the following qualifications and experienceBachelor/Master Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area) and proven track record in the pharmaceutical or related industryWork experience in leading and/or working with internal and external teams through end-to-end projects (e.g. in Development, Manufacturing, Quality) under current Good Practice (cGxP),Quality System Regulation (QSR) or similar working practicesSound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Experience with Health Authority interactionsSelf-motivated, pro-active, responsible, result-oriented and an excellent team playerExperience in working in agile environment and usage of lean toolsExcellent communication and negotiation skills in German and English with success in building trustful relationshipsRoche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.Full time