Senior Device Engineer

Role Summary

Senior Device Engineer serves as a technical leader in the design, development, and lifecycle management of drug delivery devices (e.g., prefilled syringes, vial kits) used in Amgen’s combination products. The role provides advanced engineering expertise, leads complex investigations, and influences decisions affecting Amgen’s product portfolio. It ensures robust, compliant design history files and helps advance the prefilled syringe and kit platform, while mentoring peers and representing device engineering across the organization.

• Functions as a fully competent and highly independent subject-matter expert, applying advanced engineering judgment to evaluate, adapt, and create methodologies that solve complex technical challenges.
• Leads design and development efforts, influencing technical direction and ensuring alignment with prefilled syringe and vial kit platform strategy as well as regulatory expectations.
• Hosts and facilitates design reviews and assessments, both during development as well as post-launch for commercialized devices.
• Serves as a technical reviewer and approver for design documentation, analyses, and verification/validation packages.
• Directs system-level root cause investigations with cross-functional stakeholders, ensuring robust technical justification and durable corrective actions.
• Uses statistical tools, modeling, and risk-based frameworks to diagnose issues and develop data-driven solutions.
• Oversees creation and maintenance of design specifications, technical standards, protocols, test methods, and comprehensive engineering reports.
• Leads design verification and validation work streams, FMEA leadership, and statistical process control efforts where applicable.
• Ensures technical records meet global regulatory expectations and withstand inspection scrutiny.
• Acts as a key technical representative within networked project teams, exercising influence across functions such as Product Quality, Regulatory, Process Development, Supply Chain, and external partners.
• Drives design improvements with development partners, contract manufacturers, and suppliers by integrating feedback, capability assessments, and manufacturability strategies.
• Contributes to long-term technology roadmaps and platform expansion efforts.
• Leads design changes, post-launch investigations, product optimizations, and scale-up activities.
• Supports and defends regulatory submissions, inspections, and commitments at a senior level.
• Serves as a technical mentor and coach to other core and extended team members.
• Demonstrates advanced working proficiency in 21 CFR 820 Quality System Regulation, ISO 14971 Risk Management, and design control processes.

• Required:
  
  High school diploma / GED and 10 years of Engineering and/or Operations experience OR
• Required:
  
  Associate’s degree and 8 years of Engineering and/or Operations experience OR
• Required:
  
  Bachelor’s degree and 4 years of Engineering and/or Operations experience OR
• Required:
  
  Master’s degree and 2 years of Engineering and/or Operations experience OR
• Required:
  
  Doctorate degree
• Preferred:
  Degree in Mechanical, Biomedical, or related Engineering discipline.
• Preferred:
  Extensive experience in medical device/combination product development, commercialization, and regulated manufacturing environments.
• Preferred:
  Experience with products with ophthalmic indications.
• Preferred:
  Experience with lifecycle management of commercialized medical devices or combination products.
• Preferred:
  Proven ability to lead complex, cross-functional engineering programs from concept through launch.
• Preferred:
  Deep expertise in design controls, applied statistics, reliability engineering, and advanced problem-solving methodologies.
• Preferred:
  Strong verbal and written communication skills with the ability to tailor messaging at multiple organizational levels.
• Preferred:
  Excellent communication and technical writing skill.