Director, Quality Engineering

Beacon Biosignals•Boston, MA

About The Position

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. This Director of Quality Engineering role reports to the VP of Quality and is responsible for leading a team of Quality Engineers while serving as a strategic technical leader and compliance partner to engineering leadership. The position will be located in the US, preferably in or near a Beacon hub (Boston or New York).

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
Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) - required

Nice To Haves

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

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