Design Control Engineer Iii

Data Science Jobs

St. Louis, MO, US
Base: $79,400.00 - $132,400.00; bonus/equity: 7.5%...
Design control lifecycle
Combination product development
Quality and regulatory standards
Lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle

Job Summary

  • Lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.
  • Ensures that combination product development activities are compliant with quality and regulatory standards – both internal and external.
  • The annual base salary for this position ranges from $79,400.00 to $132,400.00, eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5%.

Matching Summary

Lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.

Salary

Base: $79,400.00 - $132,400.00; Bonus/Equity: 7.5% bonus target; Benefits: Comprehensive and generous benefits package

Skills & Requirements

Must-have

  • design control lifecycle
  • combination product development
  • quality and regulatory standards
  • risk management activities
  • design validation support
  • regulatory submission data

Nice-to-have

  • human factors engineering
  • usability engineering
  • project management methodologies
  • technical leadership
  • statistical analysis of test results

Key Requirements

  • BS degree with 6-8 years experience
  • MS degree with 4-6 years experience
  • Knowledge of ISO 9001, ISO 13485, ISO 14971
  • Knowledge of 21 CFR 820, ISO 11040
  • Knowledge of EU Medical Devices Directive
  • Knowledge of EN 62366 and EU MDR
  • Proficiency in general computer software

Work Rights

Permanent work authorization in the United States

Tailored Resume

Cover Letter