Device Engineering Sr. Engineer

Device Engineering Sr. Engineer

In this vital role you will join our Device Engineering group to support device development and engineering robustness. 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 to optimize the patient experience. The Sr Engineer role is a cross‑discipline execution role within the Design for Robustness framework.

The role ensures consistent and structured application of robustness methodologies across mechanical design projects, integrating insights from device performance, sources of variation, load cases, materials, assembly, and manufacturing perspectives. While not serving as the formal discipline authority, the role strengthens project robustness execution and supports discipline SMEs under centralized governance. The Sr Engineer operates across disciplines and may execute within individual Design for Robustness disciplines;
Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, depending on project needs and targeted training. The position is based at our Amgen Massachusetts site with the possibility of a 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 Robustness Disciplines Lead.

• Independently execute tasks within one or more of the Design for Robustness disciplines;
  Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM.
• Provide technical recommendations to improve design performance, reduce sensitivity to variation, and enhance overall system robustness.
• Collaborate across robustness disciplines to identify risks and mitigations, opportunities and best trade‑off solutions.
• Contribute to continuous improvement of robustness disciplines and tools by identifying gaps, proposing improvements, and supporting implementation under governance frameworks.
• Interface effectively with discipline SMEs and incorporating guidance while maintaining ownership of robustness execution within assigned scope.
• Drive structured problem‑solving and root cause analysis for design, test, and field performance issues, ensuring robust corrective solutions.
• Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation‑driven failures.
• Apply systems‑level thinking to anticipate how design decisions impact downstream manufacturability and performance.

• Doctorate degree
• Masters degree and 2 years of Engineering experience
• Bachelors degree and 4 years of Engineering experience
• Associates degree and 8 years Engineering experience
• High school diploma / GED and 10 years Engineering experience

• 5+ years of progressive experience as a mechanical engineer.
• 3+ years of experience within development of Medical Devices, ideally Class II and Class III.
• Experience in mechanical engineering disciplines and tools, with hands‑on work in at least one Design for Robustness disciplines;
  Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, and preferably exposure to several.
• Strong interpersonal skills.
• Ability to work within cross‑cultural project teams.
• Systematic problem solver and solution developer also when presented with conflicting needs and technical issues.
• Experience in drug/device combination product design and development.
• Technical understanding of manufacturing processes (injection molding, assembly processes).
• Technical understanding of drawings and design documentation.
• Understands documentation flow for GMP deliverables.
• Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position.
• Familiar with: US Good Manufacturing Practices – 21
  
  CFR
  820;
  Quality Management – ISO 13485;
  Needle‑based injection systems for medical use – ISO 11608;
  Risk Management – ISO 14971.
• Strong communication and presentation skills.
• Fluent in English language.