Beacon Biosignals · 12 hours ago
Director, Quality Engineering
United States
Full-time
Remote
Director/Executive
10+ years expBeacon Biosignals is on a mission to revolutionize precision medicine for the brain. The Director of Quality Engineering will lead a team of Quality Engineers and act as a strategic technical leader to ensure compliance and enhance quality management systems in the development of medical devices.
Artificial Intelligence (AI)Health CareHealth DiagnosticsMachine LearningMedical Device
Responsibilities
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
Qualification
Required
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
Benefits
Equity
PTO
Other benefits
Company
Beacon Biosignals
Beacon Biosignals is a neurotechnology company that brings precision neuroscience into clinical trials and treatments.
51-200 employees
H1B Sponsorship
Beacon Biosignals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageTotal Funding
$116MKey Investors
General Catalyst
2025-11-13Series B· $86M
2021-11-08Series A· $27M
2019-06-01Seed· $3M
Leadership Team
Jacob Donoghue, MD PhD
Co-Founder and CEO
M Brandon Westover
Co-Founder
Recent News
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-12-19
MarketScreener
2025-12-16
Company data provided by crunchbase