Senior Test Engineer

TransMedics

Andover, MA, US
Base: $118,600.00 – $148,00.00; bonus/equity: elig...
Onsite
Bs in mechanical electrical or biomedical engineering
8 years experience in regulated environment
Class ii or iii medical device testing
The role is responsible for developing and overseeing testing strategies to ensure the safety and compliance of Class II/III medical devices

Job Summary

  • The role is responsible for developing and overseeing testing strategies to ensure the safety and compliance of Class II/III medical devices.
  • TransMedics is a commercial-stage company transforming organ transplant therapy with a mission to help save more patients' lives.
  • The position offers a comprehensive benefits package including medical, dental, vision, 401K, and an Employee Stock Purchase Plan.

Matching Summary

The role is responsible for developing and overseeing testing strategies to ensure the safety and compliance of Class II/III medical devices.

Salary

Base: $118,600.00 – $148,00.00; Bonus/Equity: Eligible for bonuses and equity; Benefits: Medical, dental, vision, 401K, pet insurance, ESPP

Skills & Requirements

Must-have

  • BS in Mechanical Electrical or Biomedical Engineering
  • 8 years experience in regulated environment
  • Class II or III medical device testing
  • FDA CFR 820 and ISO 13485 regulations
  • Verification and validation protocol writing

Nice-to-have

  • Six Sigma Green Belt certification
  • Minitab statistical analysis proficiency
  • Solidworks 3D modeling knowledge
  • Fast paced high energy team collaboration
  • Root cause analysis for test failures

Key Requirements

  • Minimum 8 years regulated environment experience
  • Bachelor's degree in Engineering required
  • Experience with FDA and ISO 13485 compliance

Work Rights

Not specified

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