Amgen Jobs

Senior Engineer Device Manufacturing, Amgen Denmark Device Engineering

Are you passionate about cutting-edge medical technology? Do you thrive in a collaborative environment where innovation drives patient care? Amgen, a global biotechnology leader, is expanding its device development capabilities in Denmark and is seeking a talented Senior Engineer to join our Device Engineering group.

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 summary:

Amgen 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.

As a key member of the technical team, the SE will be accountable for 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 lead the manufacturing development activities throughout the development phases and will provide an important link between manufacturing teams and the development team. The SE will set the direction for this discipline, ensuring robust process specifications are created as part of a robust design framework. As part of this, the SE will drive systematic DfM and DfA analysis, feedback, and implementation.

The SE ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program. Additionally, the SE will work closely with Amgen production sites and external suppliers on the execution of design transfers. The role may also include technical project management of a smaller engineering team of 5-10 enginners.

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 the 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 problems

• Provide 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 structuring

• Ensure risk assessment integration between requirements, risks, mitigation implementation within Design Outputs and Design Transfer, e.g., molding/metal forming – assembly – packaging – transportation

• Optimize plastic components for molding

• Optimize metal components for manufacturing, e.g., springs

• Optimize plastic and metal components for high volume feeding and assembly

• Assembly test set-up supporting transition from laboratory to commercial production

• Participate in project execution according to Robust Design paradigm and principles: kinematics, tolerance design, 2D drawings, structural analysis (FEA), materials science (especially polymers), DfM/DfA

• Prepare technical proposals for competitive bids

• Utilize project planning and monitoring methods to ensure timely completion

• Review and approve completed design work

• Actively contribute to identifying and pursuing new technological opportunities

Preferred Qualifications:

• 10+ years of progressive experience as an engineer or scientist within the appropriate field of study

• 5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III

• Fluency in English language

• Experience in technical leadership, leading a small team

• Experience in managing budgets

• Solid experience in documentation authoring from project start to end especially for DfM/DfA

• Significant experience within the working areas:

• Material science e.g., ageing of plastics and effect on device durability

• Optimizing plastic components for molding

• Optimizing metal components for manufacturing, e.g., springs

• Optimizing plastic and metal components for high volume feeding and assembly

• Assembly test set-up supporting transition from laboratory to commercial production

• Risk assessment of all steps in design transfer (e.g., molding/metal forming – assembly – packaging – transportation)

• Highly experienced in statistics, including applied statistics in manufacturing

• Technical understanding of drawings

• Experience in drug/device combination product design and development, including Design Controls and Change Control

• Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components

• Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product

• Experience in model-based design and UML and small-scale device assembly experience

• Experience 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/position

• Familiar with standards: US Good Manufacturing Practices – 21CFR820; Quality Management – ISO 13485; Risk Management – ISO 14971; EU Medical Device requirements – Council Directive 93/42/EEC

• Strong interpersonal skills

• Strong communication and presentation skills

• Ability to work within cross-cultural project teams

Why Amgen?

• Impactful Work: Contribute to life-changing solutions that directly impact patients.

• Growth Opportunities: Amgen’s pipeline offers exciting challenges and career growth.

• Inclusive Culture: We celebrate diversity and welcome candidates from all backgrounds.

Join 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 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 instantly. For more information about the position, please contact Rasmus Øhlenschlæger: rohlensc@amgen.com .