Associate Principal Engineer, Drug-device Combination Products

29

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 alignment with critical quality attributes and performance requirements.
  • Successful candidates will be eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k).

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 available; 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 custom fixture prototyping
  • Strong interpersonal collaboration skills
  • High level work ethic
  • Machine Learning (ML) familiarity

Key Requirements

  • B.S. in Mechanical Engineering
  • 10+ years regulated industry experience
  • Experience with combination products
  • US residency or visa sponsorship eligibility

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter