Base: $79,400.00 to $132,400.00; bonus/equity: 7.5...
Design control and risk management
Compliance with quality and regulatory standards
Support for 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: $79,400.00 to $132,400.00; 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 for design validation and human factors engineering
Regulatory submission data generation
Assessment of external design companies and suppliers
Support device design and manufacturing investigations
Support internal and external quality system audits
Nice-to-have
Knowledge of US and global regulations and guidance
Device risk management expertise
Familiarity with human factors and usability engineering
Project management and technical leadership
Experience with device assembly manufacturing process
Complex data analysis and mathematical calculations
Key Requirements
BS degree with 6-8 years relevant experience or MS degree with 4-6 years relevant experience
Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, EU Medical Devices Directive
Working knowledge of EN 62366 and EU Medical Devices Regulation