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).
What success looks like:
Team Leadership
- 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
Strategic Management
- 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
Technical Quality Oversight
- 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
What You Will Bring:
- 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
The salary range for this role is $195,000 – $215,000. Salary ranges are determined using current market compensation data for this role and adjusted based on experience, skills, and location. The base salary is one component of the total compensation package, which includes equity, PTO and other benefits.
At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example. As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.
