Director, Quality Engineering

<p>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. </p> <p>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).</p> <h3><strong>What success looks like: </strong></h3> <p>Team Leadership</p> <ul> <li>Supervise and develop a team of Quality Engineers, coordinating their activities to support company and departmental goals</li> <li>Build team capability through mentoring, coaching, and fostering technical expertise in regulated medical device development</li> <li>Manage workload distribution and prioritization across multiple concurrent projects and initiatives</li> <li>Drive performance management, providing regular feedback and creating development opportunities</li> </ul> <p>Strategic Management</p> <ul> <li>Partner with engineering leadership to guide Software, Machine Learning, and Hardware teams through new product development and sustaining engineering</li> <li>Champion the least burdensome approach to compliance while maintaining regulatory integrity</li> <li>Drive process improvements across the quality management system to enhance efficiency and effectiveness</li> <li>Represent Quality in executive-level discussions, audits, and regulatory interactions</li> </ul> <p>Technical Quality Oversight</p> <ul> <li>Serve as SME for hardware and software compliance processes across design, manufacturing, product release, and post-market support</li> <li>Lead product release coordination in collaboration with engineering and manufacturing teams</li> <li>Oversee Software Tool Validation program to meet regulatory and operational requirements</li> <li>Represent Beacon in second-party (customer) and third-party audits (ISO auditors) and regulatory inspections</li> <li>Drive MDR compliance and CE marking initiatives for Beacon products</li> <li>Stay current on international standards and regulations, ensuring organizational awareness</li> <li>Act as quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control</li> <li>Ensure timely project delivery on time, within scope, and in compliance with all regulatory requirements</li> </ul> <h3><strong>What You Will Bring:</strong></h3> <ul> <li>Minimum 10 years of combined software and hardware quality experience in medical device industry</li> <li>Previous experience managing teams of Quality Engineers, including performance management, mentoring, and development</li> <li>Proven ability to coordinate team activities and delegate effectively based on competency and workload</li> <li>Track record of developing direct reports and building team capability</li> <li>Experience managing competing priorities across multiple projects and teams simultaneously</li> <li>Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders</li> <li>Expert knowledge of key industry standards and regulations: 21 CFR 820, ISO 13485, IEC 60601, IEC 80601, TIR45, ISO 14971</li> <li>Demonstrated experience implementing IEC 62304</li> <li>Bachelor's degree in a relevant scientific, engineering, or related field</li> <li>Knowledge of European regulatory requirements (IVDR/MDR), including CE mark process</li> <li>Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances</li> <li>Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) - required</li> </ul> <p><span style="font-family: helvetica, arial, sans-serif;">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.</span> The base salary is one component of the total compensation package, which includes equity, PTO and other benefits.</p> <p>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.</p>