Design Control Engineer Iii

pfizer.hu

St.Louis, MO, US
Base: $79,400.00 - $132,400.00; bonus/equity: 7.5%...
Design control for biologics
Combination product development
Iso 9001, iso 13485, iso 14971
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: $79,400.00 - $132,400.00; Bonus/Equity: 7.5% of base salary; Benefits: Comprehensive and generous benefits

Skills & Requirements

Must-have

  • Design control for biologics
  • Combination product development
  • ISO 9001, ISO 13485, ISO 14971
  • 21 CFR 820, ISO 11040
  • EU Medical Devices Directive
  • Cross-functional team collaboration
  • Attention to technical details

Nice-to-have

  • Human Factors Engineering
  • Usability Engineering
  • Project management methodologies
  • Statistical analysis of test results
  • Device assembling manufacturing process

Key Requirements

  • BS degree with 6-8 years experience OR MS degree with 4-6 years experience
  • Experience in Pharmaceutical Combination Product and/or Device industries
  • Working knowledge of EN 62366 and EU Medical Devices Regulation
  • Proficiency in general computer software
  • Understand Good Manufacturing Practices (GMP)

Work Rights

Permanent work authorization required

Tailored Resume

Cover Letter