Principal Scientist, Drug/device Combination Products

Mericalherbs

Base: $153,800.00 - $242,200.00; bonus/equity: eli...
Hybrid
Combination product design controls
Regulatory compliance with fda and iso standards
Process improvement and operational excellence
This position will be responsible for leading and implementing medical device and combination product design controls for both new and inline products from early design concept 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 and inline products from early design concept through commercialization to support regulatory filing, product launch, and post-market surveillance.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and will receive a comprehensive benefits package including medical, dental, vision, retirement, paid holidays, vacation, and sick days.
  • The company embraces diversity and inclusion, encouraging employees to challenge thinking respectfully and approach problems collectively in an inclusive environment.

Matching Summary

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

Salary

Base: $153,800.00 - $242,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Combination product design controls
  • Regulatory compliance with FDA and ISO standards
  • Process improvement and operational excellence
  • Risk management for medical devices
  • Cross-functional team collaboration
  • Design history file development
  • Lean and Six Sigma initiatives

Nice-to-have

  • Strong analytical and problem-solving abilities
  • Strategic thinker with leadership influence
  • Excellent communication and presentation skills
  • Experience with FMEA and statistical sampling
  • Project management skills
  • Ability to work independently
  • Experience in continuous improvement initiatives

Key Requirements

  • B.A./B.S. in Engineering plus 15 years experience or Master’s plus 12 years
  • 10+ years in process improvement and quality management
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971
  • Experience leading DHF deliverables for combination products
  • PMP or similar certification preferred
  • Six Sigma Certification preferred
  • U.S. work authorization required

Work Rights

U.S. work authorization required

Sponsorship: available

Tailored Resume

Cover Letter