Principal Manufacturing Engineer-npi

TransMedics

Somerville, MA, USA
Base: $147,200.00 - $183,600.00; bonus/equity: eli...
10+ years fda/iso regulated experience
Npi manufacturing and design transfer
Injection molding and plastic joining
The Principal Engineer serves as the technical project leader driving the development and commercialization of perfusion set and OCS products

Job Summary

  • The Principal Engineer serves as the technical project leader driving the development and commercialization of perfusion set and OCS products.
  • This role requires extensive experience in NPI manufacturing, process development, and design transfer within an FDA-regulated medical device environment.
  • TransMedics offers a competitive salary range of $147,200 to $183,600 along with comprehensive benefits including equity and wellness resources.

Matching Summary

The Principal Engineer serves as the technical project leader driving the development and commercialization of perfusion set and OCS products.

Salary

Base: $147,200.00 - $183,600.00; Bonus/Equity: Eligible for bonuses and equity; Benefits: Medical, dental, vision, 401K, pet insurance, and ESPP

Skills & Requirements

Must-have

  • 10+ years FDA/ISO regulated experience
  • NPI Manufacturing and Design Transfer
  • Injection molding and plastic joining
  • SolidWorks 3D modeling proficiency
  • Capital equipment selection and scale-up

Nice-to-have

  • Lean Six Sigma certification
  • Minitab statistical analysis skills
  • Robotics and automated assembly expertise
  • Cross-functional leadership influence
  • Fast-paced dynamic environment adaptability

Key Requirements

  • BS in Mechanical Engineering or related discipline
  • 10+ years in medical device manufacturing
  • Proven leadership in capital equipment qualification

Work Rights

Not specified

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