Associate Principal Scientist, Drug/device Combo Products

Mayoly

Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid
10 years medical device development experience
Design history file (dhf) leadership
Fda combination product regulations knowledge
The role involves leading the implementation of design controls and device development strategies for combination products from early concept through commercialization

Job Summary

  • The role involves leading the implementation of design controls and device development strategies for combination products from early concept through commercialization.
  • Candidates must possess broad knowledge of U.S. and global medical device regulations including FDA guidance and ISO standards.
  • The position offers a competitive salary range of $142,400.00 to $224,100.00 along with comprehensive benefits including 401(k) and paid time off.

Matching Summary

The role involves leading the implementation of design controls and device development strategies for combination products from early concept through commercialization.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays

Skills & Requirements

Must-have

  • 10 years medical device development experience
  • Design history file (DHF) leadership
  • FDA combination product regulations knowledge
  • ISO 14971 risk management application
  • Cross-functional team coordination

Nice-to-have

  • Master's degree in engineering discipline
  • Experience with injection devices
  • Strategic thinker with influence skills
  • Publication and patent contributions
  • Enterprise level project leadership

Key Requirements

  • B.A./B.S. in Engineering plus 10 years experience
  • Subject matter expert in design controls
  • Knowledge of cGMP and Quality System Regulation
  • Proven track record in product design evaluation

Work Rights

Not specified

Tailored Resume

Cover Letter