Engineer

Amgen Australia Pty Ltd

Massachusetts, US
Base: $88,281.00 - $119,439.00 usd; bonus/equity: ...
Master's degree or equivalent experience
End-to-end change control execution
Design history file support
The role involves leading end-to-end preparation and execution of Change Controls within a regulated environment

Job Summary

  • The role involves leading end-to-end preparation and execution of Change Controls within a regulated environment.
  • Candidates will collaborate across robustness disciplines to identify risks and optimize product design for manufacturing.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, and flexible work models.

Matching Summary

The role involves leading end-to-end preparation and execution of Change Controls within a regulated environment.

Salary

Base: $88,281.00 - $119,439.00 USD; Bonus/Equity: Discretionary annual bonus and stock-based incentives; Benefits: Comprehensive health, dental, vision, and retirement plan

Skills & Requirements

Must-have

  • Master's degree or equivalent experience
  • End-to-end change control execution
  • Design History File support
  • Quality Management System compliance
  • Cross-functional collaboration skills

Nice-to-have

  • Experience in medical device development
  • Knowledge of injection molding processes
  • Familiarity with ISO 13485 standards
  • Systems-level thinking for manufacturability
  • Fluent English language proficiency

Key Requirements

  • Master's degree OR Bachelor's with 2 years experience
  • Experience with change control in regulated environments
  • Understanding of manufacturing processes like injection molding
  • Working knowledge of 21 CFR 820 and ISO 14971

Work Rights

Not specified

Tailored Resume

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