Device Assembly Process Engineer

AstraZeneca

Base: $79,336.80 - $119,005.20 usd annual; bonus/e...
Device/combination product assembly technical leadership
Assembly process characterization
Medical device/combination product design transfer
Support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices

Job Summary

  • Support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices.
  • Provide technical leadership in experimental design and data analysis, perform risk analyses, and support GMP runs at assembly sites.
  • Assist or lead late-stage and commercial design transfer of assembly processes to CMOs and internal facilities for parenteral biopharmaceutical or synthetic drug products.

Matching Summary

Support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices.

Salary

Base: $79,336.80 - $119,005.20 USD Annual; Bonus/Equity: short-term incentive bonus opportunity, equity-based long-term incentive program (salaried roles); Benefits: qualified retirement program [401(k) plan], paid vacation and holidays, paid leaves, health benefits

Skills & Requirements

Must-have

  • Device/Combination Product Assembly Technical Leadership
  • Assembly Process Characterization
  • Medical Device/Combination Product Design Transfer
  • Biopharmaceutical / combination drug product development
  • Combination product and cGMP regulations
  • Validation of Equipment, Process and Shipping Configurations

Nice-to-have

  • QbD, experimental design, statistics, data analysis
  • Leadership and interpersonal communication
  • Technical writing and documentation
  • injection molding and materials science of polymers
  • high degree of self-motivation
  • mechanical skill and technical rigor

Key Requirements

  • Bachelors degree and 5+ years OR Master's degree and 2+ years of med device or combination product experience
  • Mechanical Engineering, Biomedical or related engineering or pharmaceutical science field
  • Design Transfer experience or experience organizing and leading multi-functional teams

Work Rights

Not specified

Tailored Resume

Cover Letter