Principal Scientist, Combination Products - Inhalation Devices

med-in.at

Base: $156,900.00 - $247,000.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
15 years of related engineering experience
Design history file (dhf) management
Iso 14971 risk management application
The Principal Scientist position at med-in.at involves leading the design controls and development of medical devices and combination products, particularly focusing on inhalation devices. The role requires extensive experience in medical device development, compliance with regulatory requirements, and collaboration with cross-functional teams

Job Summary

  • This position leads the implementation of design controls for new and existing combination products from early concept through commercialization.
  • The successful candidate will apply extensive knowledge of FDA regulations, ISO standards, and risk management to ensure compliant product development.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k).

Matching Summary

Match Score: 85

The Principal Scientist position at med-in.at involves leading the design controls and development of medical devices and combination products, particularly focusing on inhalation devices. The role requires extensive experience in medical device development, compliance with regulatory requirements, and collaboration with cross-functional teams.

Salary

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

Skills & Requirements

Must-have

  • 15 years of related engineering experience
  • Design history file (DHF) management
  • ISO 14971 risk management application
  • FDA combination product regulations knowledge
  • Cross-functional stakeholder coordination

Nice-to-have

  • Master's degree in engineering discipline
  • Experience with dry powder inhalers
  • Enterprise level project leadership
  • Statistical sampling and control strategy
  • Strategic thinker with influence skills

Key Requirements

  • B.A./B.S. in Engineering plus 15 years experience
  • Subject matter expert in medical device design controls
  • Knowledge of U.S. and global medical device regulations
  • Proven track record managing DHF deliverables
  • VISA Sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter