Device Assembly Process Engineer

AstraZeneca

Base: $79,336.80 - 119,005.20 usd annual; bonus/eq...
Device assembly process development
Risk assessment and experimental design
Gmp batch record and validation review
The candidate will support assembly process development for medical devices and/or combination products, providing technical leadership and process characterization

Job Summary

  • The candidate will support assembly process development for medical devices and/or combination products, providing technical leadership and process characterization.
  • This role offers a competitive salary range with bonus, equity, and comprehensive benefits including retirement plans and health coverage.
  • AstraZeneca fosters an inclusive environment encouraging innovation and teamwork to deliver life-changing medicines.

Matching Summary

The candidate will support assembly process development for medical devices and/or combination products, providing technical leadership and process characterization.

Salary

Base: $79,336.80 - 119,005.20 USD Annual; Bonus/Equity: Short-term incentive bonus and equity-based long-term incentive program eligibility; Benefits: Retirement program, paid vacation, health coverage

Skills & Requirements

Must-have

  • Device assembly process development
  • Risk assessment and experimental design
  • GMP batch record and validation review
  • Design transfer to CMOs and internal facilities
  • Technical writing and documentation
  • Leadership of multifunctional teams

Nice-to-have

  • Knowledge of injection molding and polymer materials
  • Self-motivation and mechanical skill
  • Strong communication and interpersonal skills
  • Experience with QbD and statistical data analysis
  • Experience in clinical and commercial GMP runs

Key Requirements

  • Bachelor's degree with 5+ years or Master's degree with 2+ years experience
  • Experience in medical device or combination product development
  • Design transfer and multi-functional team leadership experience
  • Knowledge of cGMP regulations and validation processes
  • US travel availability 1-2 times per year

Work Rights

Not specified

Tailored Resume

Cover Letter