Senior Device Development Engineer

Career Category

Engineering

Job Description

Amgen 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 Engineer

Live

What you will do

Amgen is expanding its device development capabilities in Denmark and is seeking Senior Engineers (SE) in our Device Engineering group to support device development, documentation, and testing. 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 key members of the development team, the SEs play a central role throughout the design and development lifecycle and will be accountable for complex, multidisciplinary, cross-functional product development efforts. This includes managing interactions, dependencies, and interfaces across the full device development program. The successful candidate will help drive the design, development, and transfer of drug delivery devices.

This is a cross-discipline development execution role that integrates component design, Design for Robustness tools, device testing, and documentation (including Design History File documentation). The SEs will apply a risk-driven development mindset, drive risk analysis and mitigation, and ensure that designs and activities meet specifications and requirements and are documented accordingly.

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:

• Analyze cross-disciplinary product development problems, synthesize solution options, and apply structured, efficient approaches to analysis and design to solve complex engineering challenges
• Contribute to project execution using Robust Design principles (e.g., kinematics, tolerance design, 2D drawings, structural analysis/FEA, materials science—especially polymers, and DfM/DfA)
• Develop and qualify test methods for relevant device performance and functionality
• Execute device testing at both engineering and GMP levels
• Support technical documentation (device design and testing, design outputs, and manufacturing equipment/process/control documentation)
• Ensure DHF documentation provides clear traceability across platform, combination product, and vendor DHF structures
• Integrate requirements, risk assessments, and mitigations, and ensure implementation is reflected in design outputs
• Actively contribute to identifying and pursuing new technological opportunities

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professionals we seek have these qualifications:

• 5+ years of progressive experience as a mechanical engineer
• 3+ years of experience in medical device development (ideally Class II and Class III)
• Experience in mechanical engineering disciplines and tools, with hands-on work in at least one Design for Robustness discipline (e.g., kinematic design, tolerance design, structural strength design, material design, DFA, DFM); exposure to multiple disciplines is preferred
• Strong analytical skills and experience with structured problem-solving approaches
• Technical understanding of manufacturing processes (injection molding, assembly processes)
• Technical understanding of drawings and design documentation
• Understanding of documentation flows for GMP deliverables
• Knowledge of quality management systems and applicable laws and regulations relevant to the role
• Familiarity with standards and regulations such as: US GMP (21 CFR 820), ISO 13485, ISO 11608, and ISO 14971
• Excellent communication and presentation skills
• Ability to work within cross-functional and cross-cultural teams
• Fluency in English

Thrive

Why us

• 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: A permit to live and work in Denmark is required for this position. All applications and inquiries are treated confidentially. We encourage you to apply as soon as possible, as the selection process will start immediately (from the 12th of May). For more information about the position, please contact Rasmus Øhlenschlæger at rohlensc@amgen.com.

.