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

Newyorkbioconnect

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.
  • This role requires collaboration with cross-functional teams to support clinical introduction and commercial market approvals of innovative biologic/drug/vaccine-device combination products.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and compassionate 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 time off

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 and device product development
  • Design verification strategy execution

Nice-to-have

  • Analytical and numerical simulation experience
  • 3D CAD and rapid manufacturing techniques
  • Strong interpersonal and strategic thinking skills
  • Experience with compression/tensile testing equipment
  • Knowledge of global device regulations and standards
  • Leadership of cross-disciplinary project teams
  • Lab capability gap identification and training

Key Requirements

  • B.S. in Mechanical Engineering + 8 years experience
  • M.S. in Mechanical Engineering + 5 years experience
  • Ph.D. in Mechanical Engineering + 3 years experience
  • Leadership experience in combination product design verification
  • Strong knowledge of regulatory landscape for combination products
  • Experience with ISO and FDA device standards
  • Ability to travel
  • VISA sponsorship available

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter