Senior Device Engineer

Amgen Australia Pty Ltd

Base: $123,098.00 - $149,145.00 usd annually; bonu...
10 years engineering experience
Design controls expertise
21 cfr 820 compliance
This role serves as a technical leader responsible for the design, development, and lifecycle management of drug delivery devices used in Amgen's combination products

Job Summary

  • This role serves as a technical leader responsible for the design, development, and lifecycle management of drug delivery devices used in Amgen's combination products.
  • The successful candidate will drive cross-functional alignment, lead complex investigations, and ensure design history files are robust and compliant with global regulatory expectations.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, stock-based incentives, and flexible work models to support professional growth.

Matching Summary

This role serves as a technical leader responsible for the design, development, and lifecycle management of drug delivery devices used in Amgen's combination products.

Salary

Base: $123,098.00 - $149,145.00 USD annually; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible time-off

Skills & Requirements

Must-have

  • 10 years engineering experience
  • Design controls expertise
  • 21 CFR 820 compliance
  • ISO 14971 risk management
  • Root cause investigation leadership

Nice-to-have

  • Ophthalmic product experience
  • Cross-functional program leadership
  • Mentoring junior engineers
  • Statistical process control skills
  • Collaborative innovation culture

Key Requirements

  • Bachelor's degree and 4 years experience OR Master's and 2 years
  • Degree in Mechanical or Biomedical Engineering preferred
  • Extensive medical device commercialization experience
  • Advanced proficiency in design verification and validation

Work Rights

Not specified

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