Device Engineering Sr. Engineer

Amgen seeks a senior mechanical engineer to support drug delivery device development within their Design for Robustness framework. The role involves executing engineering tasks across multiple disciplines—including tolerance design, structural analysis, and manufacturing—while collaborating with cross-functional teams to enhance device performance and manufacturability.

Responsibilities

• Execute Design for Robustness tasks across kinematic, tolerance, structural, material, DFA, and DFM disciplines
• Provide technical recommendations to reduce design sensitivity to variation and enhance system robustness
• Collaborate across disciplines to identify risks, opportunities, and optimal trade-off solutions
• Drive structured problem-solving and root cause analysis for design and field performance issues
• Interface with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures

Requirements

• Bachelor's degree and 4+ years engineering experience (or equivalent qualification pathway)
• 5+ years progressive mechanical engineering experience preferred
• 3+ years medical device development experience, ideally Class II/III devices
• Hands-on experience in at least one Design for Robustness discipline
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, and GMP requirements
• Strong problem-solving skills and cross-functional collaboration ability
• Technical understanding of manufacturing processes and design documentation