Design Control Engineer Iii

pfizer.ca

St.Louis, MO, US
$79,400.00 - $132,400.00; bonus target of 7.5%; co...
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.
  • We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.

Matching Summary

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

Salary

$79,400.00 - $132,400.00; Bonus target of 7.5%; Comprehensive benefits

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
  • Device assembling manufacturing process

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
  • Permanent work authorization in the United States

Work Rights

Permanent work authorization required

Tailored Resume

Cover Letter