Director, Quality Engineering

Beacon Biosignals

Boston, US
Base: $195,000 – $215,000; bonus/equity: includes ...
Remote
Software and hardware quality experience
Medical device industry compliance
Quality management system improvements
Beacon Biosignals is revolutionizing precision medicine for the brain with its at-home EEG platform and AI algorithms

Job Summary

  • Beacon Biosignals is revolutionizing precision medicine for the brain with its at-home EEG platform and AI algorithms.
  • This role involves leading a team of Quality Engineers, partnering with engineering leadership, and ensuring compliance across design, manufacturing, and post-market support.
  • The company seeks individuals with cultural and scientific impact driven by curiosity, simplicity, composability, self-service, and empathy.

Matching Summary

Beacon Biosignals is revolutionizing precision medicine for the brain with its at-home EEG platform and AI algorithms.

Salary

Base: $195,000 – $215,000; Bonus/Equity: includes equity; Benefits: includes PTO and other benefits

Skills & Requirements

Must-have

  • Software and hardware quality experience
  • Medical device industry compliance
  • Quality Management System improvements
  • Software Tool Validation oversight
  • MDR compliance and CE marking
  • International standards and regulations

Nice-to-have

  • Leading by example
  • Avid curiosity and empathy
  • Diverse team building
  • Bias towards simplicity
  • Self-service mindset

Key Requirements

  • 10+ years software/hardware quality experience
  • Experience managing Quality Engineers
  • 21 CFR 820, ISO 13485, IEC 60601 knowledge
  • IEC 62304 implementation experience
  • Bachelor's degree in relevant field
  • Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE)

Work Rights

Not specified

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