Design Control Engineer Ii

pfizer.ch

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 and will lead design control projects for biologics modalities developed as prefilled syringe-based combination products

Job Summary

  • This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA and will lead design control projects for biologics modalities developed as prefilled syringe-based combination products.
  • The role ensures compliance with internal and external quality and regulatory standards and supports clinical trials and commercial licensures through design control and risk management activities.
  • Pfizer offers a comprehensive benefits package including a 401(k) plan with matching contributions, paid leave, health benefits, and a bonus target of 7.5% of base salary.

Matching Summary

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

Salary

Base: $68,600.00 to $114,300.00; Bonus/Equity: 7.5% of base salary; Benefits: Comprehensive benefits including 401(k), paid leave, and 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
  • Proficiency in general computer software

Nice-to-have

  • Knowledge of US and global regulations
  • Device risk management expertise
  • Human Factors Engineering familiarity
  • Project management methodologies
  • Device assembling manufacturing process
  • Complex data analysis skills
  • Statistical sampling and analysis

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, EU Medical Devices Directive and Regulation
  • Permanent US work authorization required
  • No US work visa sponsorship available

Work Rights

Permanent US work authorization required

Tailored Resume

Cover Letter