Senior Engineer Device Manufacturing, Amgen Denmark Device Engineering – Amgen-Workday – Søborg

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Job summaryAmgen is currently expanding device development capabilities in Denmark and is seeking a Senior Engineer (SE) in our Device Engineering group in Denmark to support device development and device Manufacturing. In support of Amgen’s mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize, and continuously improve drug delivery devices in order to optimize the patient experience. The SE will be accountable to complex, multi-disciplinary and cross-functional product development efforts, managing the interactions, dependencies, and interfaces across a full device development program. The successful candidate will be a key member of the technical team that progresses towards the successful design, development, and transfer of drug delivery devices. The SE ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program. The SE is also responsible for managing the integration of the system components and ensuring interfaces towards DfX. The SE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.The position is based at our Amgen Denmark device engineering and testing site at Søborg with possibility of flexible working arrangement meeting business and private needs. You will be joining Amgen device development team consisting of 50+ engineers. This position will report to the program lead/device workstream lead.Responsibilities:Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problemsProvide direction and support all technical documentation (Device Design/Testing, Design Outputs, Manufacturing equipment/process/control)Be accountable for DHF documentation to ensure a clear line between platform, combination product and vendor DHF structuringEnsure risk assessment integration between requirements, risks, mitigation implementation within Design Outputs and Tech Transfer (part of Design Transfer, e.g., molding/metal forming – assembly – packaging – transportation)Manages / maintains the traceability between risk (Use and Functional) and RequirementsOptimize plastic components for moldingOptimize metal components for manufacturing, e.g., springsOptimize plastic and metal components for high volume feeding and assemblyAssembly test set-up supporting transition from laboratory to commercial productionParticipate in project execution according to Robust Design paradigm and principles: kinematics, tolerance design, 2D drawings, structural analysis (FEA), materials science (especially polymers), DfM/DfAPrepare technical proposals for competitive bidsUtilize project planning and monitoring methods to ensure timely completionReview and approve completed design workActively contribute to identifying and pursuing new technological opportunitiesPreferred Qualifications:10+ years of progressive experience as an engineer or scientist within the appropriate field of study5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class IIIFluency in English languageSolid experience in documentation authoring from project start to end especially for DfM/DfXSignificant experience within the working areas:Material science e.g., ageing of plastics and effect on device durabilityOptimizing plastic components for moldingOptimizing metal components for manufacturing, e.g., springsOptimizing plastic and metal components for high volume feeding and assemblyAssembly test set-up supporting transition from laboratory to commercial productionRisk assessment of all steps in Tech transfer (part of Design transfer, e.g., molding/metal forming – assembly – packaging – transportation)Highly experienced in statistics, including applied statistics in manufacturingTechnical understanding of drawingsExperience in drug/device combination product design and developmentDemonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and componentsDemonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/productExperience in model-based design and UML and small-scale device assembly experienceExperience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/positionFamiliar with standards: US Good Manufacturing Practices – 21CFR820; Quality Management – ISO 13485; Risk Management – ISO 14971; EU Medical Device requirements – Council Directive 93/42/EECStrong interpersonal skillsStrong communication and presentation skillsAbility to work within cross-cultural project teamsApplication:Please note that it is required to have a permit to live and work in Denmark for the position. All applications and contacts are confidential. We want your application as soon as possible, since selection starts in August. For more information about the position, please contact Peter D K Soelberg: psoelber@amgen.com.Join UsIf you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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