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

39med

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 and external partners to support clinical introduction and commercial market approvals.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, 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: Comprehensive medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

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

Nice-to-have

  • Leadership and strategic thinking
  • Material characterization and failure analysis
  • 3D CAD and rapid manufacturing techniques
  • Strong interpersonal and communication skills
  • Experience with accelerated aging studies
  • Collaboration and ideation facilitation
  • Knowledge of global device regulations and standards

Key Requirements

  • B.S. in Mechanical Engineering plus 8 years experience
  • M.S. in Mechanical Engineering plus 5 years experience
  • Ph.D. in Mechanical Engineering plus 3 years experience
  • Leadership experience in combination product design verification
  • Strong regulatory knowledge for drug-device products
  • Experience with ISO and FDA standards
  • Ability to travel
  • U.S. or Puerto Rico residency

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter