Design Control Engineer Ii

Data Science Jobs

St.Louis, MO, US
Base: $68,600.00 - $114,300.00; bonus/equity: 7.5%...
Design control lifecycle management
Combination product development
Regulatory 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: 401(k) plan, paid time off, health benefits

Skills & Requirements

Must-have

  • Design control lifecycle management
  • Combination product development
  • Regulatory compliance
  • Risk management activities
  • Cross-functional team collaboration
  • Attention to technical details

Nice-to-have

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

Key Requirements

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

Work Rights

Permanent work authorization

Tailored Resume

Cover Letter