Device Engineering Sr Engineer - Cambridge MA

Device Engineering Senior Engineer

What you will do:

In this vital role you will join our Device Engineering group to support device development and engineering robustness. You will work within Amgen’s mission to serve patients, helping to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience. The role operates within the Design for Robustness framework, ensuring consistent application of robustness methodologies across mechanical design projects and coordinating with discipline SMEs.

• Independently execute tasks within one or more 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 incorporate guidance while maintaining ownership of robustness execution within the 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
• Master’s degree and 2+ years of engineering experience
• Bachelor’s degree and 4+ years of engineering experience
• Associate’s degree and 8+ years of engineering experience
• High school diploma / GED and 10+ years of engineering experience

• 5+ years of progressive experience as a mechanical engineer
• 3+ years of experience developing medical devices, ideally Class II and Class III
• Hands‑on experience with at least one Design for Robustness discipline (Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM)
• Strong interpersonal skills
• Ability to work within cross‑cultural project teams
• Systematic problem‑solving and solution development skills in the presence of 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
• Knowledge of GMP documentation flow and relevant quality management systems (ISO 13485, ISO 14971, 21
  
  CFR
  820, ISO 11608)
• Strong communication and presentation skills
• Fluency in English

Auto req : 471894

Salary Range:  USD –  USD

Location: Cambridge, Massachusetts

Job Category: Management