Principal Scientist, Drug/device Combination Products

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Base: $153,800.00 - $242,200.00; bonus/equity: eli...
Hybrid
Medical device and 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 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 annual bonus and long-term incentive, and the company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, and paid time off.

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: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • medical device and combination product design controls
  • regulatory compliance with FDA and ISO standards
  • process improvement and operational excellence
  • risk management for combination products
  • cross-functional collaboration
  • design history file (DHF) development
  • data analytics and key performance indicators

Nice-to-have

  • strategic thinking and influencing skills
  • project management expertise
  • strong communication and negotiation skills
  • experience with lean and six sigma initiatives
  • ability to work independently
  • fostering cross-functional collaboration
  • training material development

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 systems
  • knowledge of FDA, ISO, and global combination product regulations
  • experience leading DHF deliverables for combination products
  • PMP or similar project management certification (preferred)
  • Six Sigma Certification (preferred)
  • Quality Engineering Certification (preferred)
  • US work authorization required
  • experience with FMEA and statistical sampling

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter