Engineer I

About the role

Amgen is seeking an Engineer I to join the development and sustaining device engineering team responsible for electromechanical device platforms used in drug‑device combination products. The role focuses on ensuring product safety, efficacy and functionality throughout the product lifecycle.

Key responsibilities

• Provide guidance on combination product and device design requirements and specifications.
• Lead product test strategies and execution to demonstrate safety, performance, and efficacy.
• Manage combination product and device Design History Files.
• Analyze data to support design acceptance, performance capability, and failure analysis.
• Create and drive test protocols, methods, and reports.
• Transfer technical information to manufacturing sites and support scale‑up and launches.
• Engage suppliers and development partners regarding specifications and quality levels.
• Provide authorship and technical leadership for regulatory filings.
• Manage project scope, schedule, and budget.
• Own and support quality records, change records, and deviations.
• Support device design complaint investigations and continuous improvement.
• Collaborate with Process Development and external partners as a technical authority.

Required profile

• Experience with combination product and device design.
• Ability to lead product testing strategies.
• Experience managing Design History Files.
• Proficiency in data analysis for design acceptance and failure analysis.
• Experience supporting regulatory filing documentation.
• Project management experience covering scope, schedule, and budget.
• Ability to work with suppliers and manufacturing sites.

Required skills

• Device design
• Design History File management
• Test protocol development
• Data analysis
• Failure analysis
• Regulatory filing documentation
• Project scope and schedule management