Engineer II

Job Summary

Engineer II – responsible for development and sustaining of electromechanical device platforms for combination product and device integration within a multidisciplinary medical device team.

• Provide guidance on combination product and device design requirements and specifications.
• Lead product test strategies and execution to demonstrate product 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.
• Apply engineering practices to gather user requirements and translate them into documentation.
• Engage suppliers and development partners regarding specifications and quality levels.
• Provide authorship and expert 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 tracking for timely resolution and continuous improvement.
• Collaborate with Process Development and external partners as a technical authority.

• Basic Qualifications
  • Master’s degree OR Bachelor’s degree with ≥2 years engineering/operations experience OR Associate’s degree with ≥6 years engineering/operations experience OR High school diploma/GED with ≥8 years engineering/operations experience.
• Preferred Qualifications
  • Bachelor’s degree in engineering or related science with 5+ years relevant experience, with demonstrated ability in an operations/manufacturing environment.
  • Experience in medical device, pharmaceutical, or similar regulated industry.
  • Background in development and commercialization of medical devices and knowledge of manufacturing processes.
  • Knowledge of Quality System Regulation – 21 CFR 820, ISO 13485, ISO 14971.
  • Excellent communication and technical writing skills.

• Competitive base salary (salary range 97,109.10 USD –  USD for the U.S.); actual salary varies with experience and qualifications.
• Health, dental, vision, life, and disability insurance.
• Retirement and Savings Plan with company contributions.
• Flexible spending accounts.
• Discretionary annual bonus program and possible stock‑based long‑term incentives.
• Generous paid time off and flexible work models where possible.
• Career development opportunities and collaborative culture.

Amgen is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We provide reasonable accommodations for people with disabilities.