How you will make an impact:

  • Interpreting standard’s requirements as they apply to medical devices
  • Participating in conceptual design discussions, design reviews, requirements development, bench testing, and formal design verification testing
  • Preparing medical device samples for testing
  • Completing internal test records and formal Test Report Forms (TRF) for applicable 60601 standards
  • Writing test plans and test procedures
  • Coordinating tests with contract test laboratories
  • Review and analysis of Compliance Test Reports
  • Contributing to design failure investigations and root-cause analysis
  • Participating in and contributing towards regulatory submissions
  • Continuously improving all processes and procedures

To be successful in this role, you will need the following skills and experience:

  • BS degree in Electrical and/or Biomedical Engineering
  • Sound understanding of engineering fundamentals
  • Proficiency with basic electrical circuit analysis
  • Understanding of transformers, power electronics
  • Ability to work as part of an interdisciplinary team
  • Self-motivated and able to self-prioritize
  • Ability to clearly explain objectives
  • Medical device industry experience preferred
  • Familiarity with the 60601 series of standards
  • Experience with research, development, and product testing
  • Broad measurement instrument knowledge

Job Category: Engineering
Job Location: Boston Palo Alto
Job Type: Full Time Part Time

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