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Director, Quality Engineering

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Beacon Biosignals

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Location:
United States , Boston

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

195000.00 - 215000.00 USD / Year
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Job Description:

Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at-home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Waveband EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon’s Clinico-EEG database contains EEG data from nearly 100,000 patients, and our cloud-native analytics platform powers large-scale RWD/RWE retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology.

Job Responsibility:

  • Supervise and develop a team of Quality Engineers, coordinating their activities to support company and departmental goals
  • Build team capability through mentoring, coaching, and fostering technical expertise in regulated medical device development
  • Manage workload distribution and prioritization across multiple concurrent projects and initiatives
  • Drive performance management, providing regular feedback and creating development opportunities
  • Partner with engineering leadership to guide Software, Machine Learning, and Hardware teams through new product development and sustaining engineering
  • Champion the least burdensome approach to compliance while maintaining regulatory integrity
  • Drive process improvements across the quality management system to enhance efficiency and effectiveness
  • Represent Quality in executive-level discussions, audits, and regulatory interactions
  • Serve as SME for hardware and software compliance processes across design, manufacturing, product release, and post-market support
  • Lead product release coordination in collaboration with engineering and manufacturing teams
  • Oversee Software Tool Validation program to meet regulatory and operational requirements
  • Represent Beacon in second-party (customer) and third-party audits (ISO auditors) and regulatory inspections
  • Drive MDR compliance and CE marking initiatives for Beacon products
  • Stay current on international standards and regulations, ensuring organizational awareness
  • Act as quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control
  • Ensure timely project delivery on time, within scope, and in compliance with all regulatory requirements

Requirements:

  • Minimum 10 years of combined software and hardware quality experience in medical device industry
  • Previous experience managing teams of Quality Engineers, including performance management, mentoring, and development
  • Proven ability to coordinate team activities and delegate effectively based on competency and workload
  • Track record of developing direct reports and building team capability
  • Experience managing competing priorities across multiple projects and teams simultaneously
  • Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders
  • Expert knowledge of key industry standards and regulations: 21 CFR 820, ISO 13485, IEC 60601, IEC 80601, TIR45, ISO 14971
  • Demonstrated experience implementing IEC 62304
  • Bachelor's degree in a relevant scientific, engineering, or related field
  • Knowledge of European regulatory requirements (IVDR/MDR), including CE mark process
  • Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances
  • Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) - required
What we offer:
  • equity
  • PTO

Additional Information:

Job Posted:
March 08, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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