Associate Principal Engineer, Drug-device Combination Products

Mericalherbs

Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid
10+ years regulated industry experience
Process validation iq oq ppq documentation
Automated assembly equipment design
This position contributes to high impact, complex, cross-functional teams developing devices like autoinjectors, inhalers, and infusion pumps from conception through launch

Job Summary

  • This position contributes to high impact, complex, cross-functional teams developing devices like autoinjectors, inhalers, and infusion pumps from conception through launch.
  • The role requires hands-on factory floor work to interrogate device supplier processes and ensure robust combination product quality control strategies.
  • Successful candidates will receive a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligibility.

Matching Summary

This position contributes to high impact, complex, cross-functional teams developing devices like autoinjectors, inhalers, and infusion pumps from conception through launch.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 10+ years regulated industry experience
  • Process validation IQ OQ PPQ documentation
  • Automated assembly equipment design
  • DFMEA and PFMEA authoring
  • Vision systems and ultrasonic welding
  • Equipment qualification requirements

Nice-to-have

  • SOLIDWORKS CAD design knowledge
  • 3D printing and prototyping skills
  • Custom fixture fabrication ability
  • Strong interpersonal collaboration skills
  • High level work ethic

Key Requirements

  • B.S. in Mechanical Engineering or related field
  • 10+ years of regulated industry experience
  • Experience with combination product assembly
  • VISA Sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter