Principal Scientist, Combination Products - Inhalation Devices

Merck & Co., Inc.

Rahway, NJ, US
Base: $156,900.00 - $247,000.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
15 years of related engineering experience
Medical device design controls implementation
Risk management and iso 14971 knowledge
Merck & Co., Inc. is seeking a Principal Scientist for Combination Products specializing in inhalation devices. This hybrid position involves leading medical device and combination product design controls from concept through commercialization, requiring extensive experience in product development and regulatory compliance

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 possess broad knowledge of medical device development, design controls, and risk management while adhering to FDA Human Factors guidance and global regulations.
  • The successful candidate is eligible for an annual bonus, long-term incentive, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking a Principal Scientist for Combination Products specializing in inhalation devices. This hybrid position involves leading medical device and combination product design controls from concept through commercialization, requiring extensive experience in product development and regulatory compliance.

Salary

Base: $156,900.00 - $247,000.00; Bonus/Equity: Annual bonus and long-term incentive available; Benefits: Comprehensive package including medical, dental, vision, 401(k), and paid time off

Skills & Requirements

Must-have

  • 15 years of related engineering experience
  • Medical device design controls implementation
  • Risk management and ISO 14971 knowledge
  • DHF deliverable leadership for medical devices
  • FDA combination product regulatory requirements

Nice-to-have

  • Master's degree in engineering discipline
  • Experience with drug-device combination products
  • Enterprise-level project development leadership
  • Statistical sampling and control strategy expertise
  • Publication and patent generation activities

Key Requirements

  • B.A./B.S. in Mechanical, Biomedical, or Industrial Engineering
  • Minimum 15 years of related experience
  • Proven track record managing Design History Files (DHF)
  • Subject matter expert in medical device design controls
  • Knowledge of U.S. and global medical device regulations

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter