Design Control Engineer Ii

pfizer.hu

St.Louis, MO, US
$68,600.00 to $114,300.00; bonus target of 7.5%; c...
Design control for biologics
Prefilled syringe combination products
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

$68,600.00 to $114,300.00; Bonus target of 7.5%; Comprehensive benefits

Skills & Requirements

Must-have

  • Design control for biologics
  • Prefilled syringe combination products
  • Quality and regulatory standards
  • ISO 9001, ISO 13485, ISO 14971
  • 21 CFR 820, ISO 11040
  • EU Medical Devices Directive
  • EN 62366, EU Medical Devices Regulation

Nice-to-have

  • US and global Regulations
  • FDA and ICH guidance
  • Syringes/injectors, luer connectors
  • Combination products quality system
  • Human Factors Engineering - Usability Engineering
  • Project management methodologies
  • Device assembling manufacturing process

Key Requirements

  • BS degree with 3+ years experience
  • MS degree with 0+ years experience
  • Working knowledge of regulations and standards
  • Independent work with minimal supervision
  • Attention to technical details and accuracy
  • Prioritize multiple responsibilities
  • Work collaboratively in cross functional teams
  • Excellent communication and interpersonal skills
  • Proficiency in general computer software
  • Understand Good Manufacturing Practices (GMP)

Work Rights

Permanent work authorization in the United States

Tailored Resume

Cover Letter