Principal Scientist, Drug/device Combination Products

539

New Jersey, United States
$153,800.00 - $242,200.00; bonus/equity: annual bo...
Hybrid
Combination product design controls
Risk management processes
Operational excellence tools
This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance

Job Summary

  • This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.
  • The role will also be responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.

Matching Summary

This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.

Salary

$153,800.00 - $242,200.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Combination product design controls
  • Risk management processes
  • Operational excellence tools
  • Regulatory requirements alignment
  • Cross-functional team collaboration

Nice-to-have

  • Foster a culture of operational excellence
  • Leverage data analytics
  • Strategic thinker
  • Influence without formal authority

Key Requirements

  • 15 years of related experience with B.A./B.S.
  • 12 years of related experience with Master's degree
  • 10+ years in process improvement, QMS, operational excellence, product development
  • Hands-on experience with combination products
  • Proven track record of driving lean and six sigma
  • Knowledge of US and global regulations

Work Rights

Not specified

Tailored Resume

Cover Letter