Principal Scientist, Combination Products - Inhalation Devices

29

Rahway, NJ, USA
Base: $156,900.00 - $247,000.00; bonus/equity: ann...
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15 years related experience
Design history file (dhf) leadership
Fda combination product regulations
** The job posting is for a Principal Scientist specializing in Combination Products related to inhalation devices at a company located in Rahway, NJ. The role involves leading medical device design controls, ensuring compliance with regulatory standards, and collaborating with cross-functional teams throughout the product development lifecycle. **

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.
  • The incumbent must apply knowledge of product development and design control principles to support clinical and commercial combination product development and launches in accordance with regulatory requirements.
  • The successful candidate is eligible for an annual bonus, long-term incentive, and a comprehensive package of benefits including medical, dental, vision, and retirement plans.

Matching Summary

Match Score: 75

** The job posting is for a Principal Scientist specializing in Combination Products related to inhalation devices at a company located in Rahway, NJ. The role involves leading medical device design controls, ensuring compliance with regulatory standards, and collaborating with cross-functional teams throughout the product development lifecycle. **

Salary

Base: $156,900.00 - $247,000.00; Bonus/Equity: Annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays

Skills & Requirements

Must-have

  • 15 years related experience
  • Design history file (DHF) leadership
  • FDA combination product regulations
  • ISO 14971 risk management
  • Cross-functional team coordination

Nice-to-have

  • Master's degree in engineering
  • Enterprise-level project leadership
  • Statistical sampling expertise
  • Publication and patent contributions
  • Strategic influence without authority

Key Requirements

  • B.A./B.S. in Engineering plus 15 years experience
  • Knowledge of FDA cGMP and Quality System Regulation
  • Experience with ISO 11608 and ISO 11040 standards
  • VISA Sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter