Senior Device Development Engineer

Job title:

Senior Device Development Engineer

Company:

Amgen

Job description

Career Category EngineeringJob DescriptionAmgen focuses on addressing high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. Since its inception in 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, reaching millions of patients globally and developing a pipeline of medicines with transformative potential.Senior Device Development EngineerLiveWhat you will doAmgen is expanding its device development capabilities in Denmark and is seeking a Senior Engineer (SE) in our Device Engineering group to support device design and manufacturing development with a focus on injection moulding. The Device Engineering group at Amgen is a diverse team dedicated to identifying, developing, commercializing, and continuously improving drug delivery devices to optimize the patient experience.As a key member of the development team, the SE will have a central role throughout the design and development process, where they will lead device manufacturing development activities, including DfM/DfA, process requirements definition, process characterization, risk management, and supplier engagement. The successful candidate will provide the crucial link between design and development, manufacturing, and design transfer teams.Come be part of a global company of more than 27,000 employees worldwide, and work at the Device Engineering hub in Denmark together with 60+ medical device professionals.Let’s do this. Let’s change the world.In this vital role, you will:Lead and execute cross-disciplinary analysis and problem solving to support the product development processDevelop and implement structured, efficient approaches to analysis and design to solve complex engineering problemsOptimize plastic and metal component designs for high-volume, automated feeding and assemblyParticipate in project execution according to Robust Design principlesProvide direction and execution for technical documentation in areas such as device design, testing, Design Outputs, manufacturing equipment/process/controlEnsure risk assessment integration between requirements, risks, and mitigation implementation within Design Outputs and Design Transfer

Be accountable for parts of the DHF documentation, ensuring a clear distinction between platform, combination product, and vendor DHF structuringWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications:At least 6-8 years of progressive experience as an engineer or scientist in relevant fields (medical device development, manufacturing, etc.)5+ years of project leadership experience in a development, research, or manufacturing environment, ideally with medical devices (Class II and Class III)Solid experience in medical device manufacturing and development processes, including experience working under Design ControlsProficiency in Design for Manufacturing (DfM) and Design for Assembly (DfA)Extensive experience in documentation authoring, especially for regulatory compliance and quality management systemsStrong analytical skills and experience with structured problem-solving approachesProficiency in materials science, particularly polymers and metals used in medical devicesExcellent communication and presentation skillsAbility to work within cross-functional and cross-cultural teamsFluency in EnglishThriveWhy usImpactful Work: Contribute to life-changing solutions that directly impact patientsGrowth Opportunities: Amgen’s pipeline offers exciting challenges and career growthInclusive Culture: We celebrate diversity and welcome candidates from all backgroundsJoin Us! If you’re ready to make a difference and be part of a dynamic team, apply now! Let’s shape the future of healthcare together.Please note: A permit to live and work in Denmark is required for this position. All applications and contacts are confidential. We want your application as soon as possible, as the selection process starts immediately. For more information about the position, please contact Rasmus Øhlenschlæger at rohlensc@amgen.com..

Expected salary

Location

Søborg, Hovedstaden

Job date

Sun, 04 Aug 2024 07:19:01 GMT

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