Design Control Engineer Ii

pfizer.ca

St.Louis, MO, US
Base: $68,600.00 - $114,300.00; bonus/equity: 7.5%...
Design control and risk management
Combination product development
Regulatory standards compliance
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: Comprehensive benefits package including 401(k), paid time off, medical, dental, vision

Skills & Requirements

Must-have

  • Design control and risk management
  • Combination product development
  • Regulatory standards compliance
  • Human factors engineering assessments
  • Regulatory submission data support
  • Device design and manufacturing investigations

Nice-to-have

  • US and global regulations knowledge
  • Syringes/injectors ISO standards
  • Statistical sampling plan understanding
  • Human Factors Engineering - Usability Engineering
  • Project management methodologies

Key Requirements

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

Work Rights

Permanent work authorization required

Tailored Resume

Cover Letter