Principal Scientist, Drug/device Combination Products

leHACK

Base: $153,800.00 - $242,200.00; bonus/equity: ann...
Hybrid
Combination product design controls
Regulatory compliance fda 21 cfr part 820
Risk management processes
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 includes identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
  • The successful candidate will be eligible for an annual bonus and long-term incentive, and the company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, and vacation.

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

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

Skills & Requirements

Must-have

  • Combination product design controls
  • Regulatory compliance FDA 21 CFR Part 820
  • Risk management processes
  • Operational excellence tools
  • Cross-functional collaboration
  • Design history file (DHF) management

Nice-to-have

  • Lean and Six Sigma initiatives
  • Project management skills
  • Strong interpersonal and communication skills
  • Strategic thinking and influencing
  • Data analytics and KPI monitoring
  • Change management leadership

Key Requirements

  • B.A./B.S. in Engineering plus 15 years experience or Master’s plus 12 years
  • 10+ years process improvement and quality management experience
  • Knowledge of global combination product regulations
  • Experience leading DHF deliverables
  • PMP or similar project management certification (preferred)
  • Six Sigma Certification (preferred)
  • US work authorization required

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter