Associate Principal Scientist, Combination Product Design Verification (associate Director Equivalent)

medhunter.de

Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Combination product design verification
Design verification test method development
Cross-functional team collaboration
The Associate Principal Scientist will lead the definition and execution of design verification strategies and design transfers for testing readiness of combination products

Job Summary

  • The Associate Principal Scientist will lead the definition and execution of design verification strategies and design transfers for testing readiness of combination products.
  • The role requires collaboration with cross-functional teams to support clinical introduction and commercial market approvals of novel biologic/drug/vaccine-device combination products.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement, paid holidays, vacation, and sick days.

Matching Summary

The Associate Principal Scientist will lead the definition and execution of design verification strategies and design transfers for testing readiness of combination products.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Combination product design verification
  • Design verification test method development
  • Cross-functional team collaboration
  • Regulatory submission authoring
  • Design control and risk management
  • Drug-device combination product expertise

Nice-to-have

  • Analytical and numerical simulation experience
  • 3D CAD and rapid manufacturing techniques
  • Strong interpersonal and strategic thinking skills
  • Lab capability gap identification and training
  • Excellent communication and project management

Key Requirements

  • B.S. in Mechanical Engineering + 8 years experience or M.S. + 5 years or Ph.D. + 3 years
  • Leadership experience in combination product design verification
  • Strong knowledge of regulatory standards and design controls
  • Experience authoring regulatory submissions (INDs, NDAs, BLAs)
  • Ability to travel
  • US and Puerto Rico residents only

Work Rights

US and Puerto Rico residents only

Sponsorship: available

Tailored Resume

Cover Letter