Design Control Engineer Ii

pfizer.de

St. Louis, MO, US
Base: $68,600.00 to $114,300.00; bonus/equity: 7.5...
Design control and risk management
Compliance with quality and regulatory standards
Support design validation and human factors engineering
This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA

Job Summary

  • This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA.
  • The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.
  • 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

This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA.

Salary

Base: $68,600.00 to $114,300.00; Bonus/Equity: 7.5% target bonus; Benefits: 401(k) with matching, paid leave, health coverage

Skills & Requirements

Must-have

  • Design control and risk management
  • Compliance with quality and regulatory standards
  • Support design validation and human factors engineering
  • Regulatory submission data generation
  • Support device design and manufacturing investigations
  • Cross functional team collaboration

Nice-to-have

  • Knowledge of US and global regulations
  • Device risk management expertise
  • Human factors and usability engineering familiarity
  • Project management methodologies
  • Device assembly manufacturing process knowledge
  • Complex data analysis skills

Key Requirements

  • BS degree in Science & Engineering 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 and EU Medical Devices Directive
  • Authorized to work in the U.S. without visa sponsorship
  • Minimum 3 years relevant pharmaceutical combination product/device experience

Work Rights

Permanent work authorization in the United States required

Tailored Resume

Cover Letter