Design Control Engineer Ii

pfizer.dk

St.Louis, MO, US
Base: $68,600.00 - $114,300.00; bonus/equity: 7.5%...
Design control lifecycle
Combination product development
Quality and regulatory standards
The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle

Job Summary

  • The incumbent will 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

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

Salary

Base: $68,600.00 - $114,300.00; Bonus/Equity: 7.5% bonus target; Benefits: 401(k) with match, paid time off, medical, dental, vision

Skills & Requirements

Must-have

  • Design control lifecycle
  • Combination product development
  • Quality and regulatory standards
  • Risk management activities
  • Regulatory submission data
  • Device design and manufacturing

Nice-to-have

  • Human Factors Engineering
  • Usability Engineering
  • Project management methodologies
  • Technical leadership
  • Statistical analysis
  • Device assembling manufacturing

Key Requirements

  • BS degree with 3+ years experience
  • MS degree with 0+ years experience
  • Working knowledge of ISO 9001, ISO 13485, ISO 14971
  • Working knowledge of 21 CFR 820, ISO 11040
  • Working knowledge of EU Medical Devices Directive
  • Working knowledge of EN 62366
  • Working knowledge of EU Medical Devices Regulation
  • Permanent work authorization in the United States

Work Rights

Permanent work authorization required

Tailored Resume

Cover Letter