Director, Quality Engineering New Boston, MA - Remote

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.This Director of Quality Engineering 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: Supervise and develop a team of Quality Engineers, coordinating their activities to support company and departmental goalsBuild team capability through mentoring, coaching, and fostering technical expertise in regulated medical device developmentManage workload distribution and prioritization across multiple concurrent projects and initiativesDrive performance management, providing regular feedback and creating development opportunitiesStrategic Management Partner with engineering leadership to guide Software, Machine Learning, and Hardware teams through new product development and sustaining engineeringChampion the least burdensome approach to compliance while maintaining regulatory integrityDrive process improvements across the quality management system to enhance efficiency and effectivenessRepresent Quality in executive-level discussions, audits, and regulatory interactionsTechnical Quality Oversight Serve as SME for hardware and software compliance processes across design, manufacturing, product release, and post-market supportLead product release coordination in collaboration with engineering and manufacturing teamsOversee Software Tool Validation program to meet regulatory and operational requirementsRepresent Beacon in second-party (customer) and third-party audits (ISO auditors) and regulatory inspectionsDrive MDR compliance and CE marking initiatives for Beacon productsStay current on international standards and regulations, ensuring organizational awarenessAct as quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process controlEnsure timely project delivery on time, within scope, and in compliance with all regulatory requirementsWhat You Will Bring: Minimum 10 years of combined software and hardware quality experience in medical device industryPrevious experience managing teams of Quality Engineers, including performance management, mentoring, and developmentProven ability to coordinate team activities and delegate effectively based on competency and workloadTrack record of developing direct reports and building team capabilityExperience managing competing priorities across multiple projects and teams simultaneouslyExceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholdersExpert knowledge of key industry standards and regulations: 21 CFR 820, ISO 13485, IEC 60601, IEC 80601, TIR45, ISO 14971Demonstrated experience implementing IEC 62304Bachelor's degree in a relevant scientific, engineering, or related fieldKnowledge of European regulatory requirements (IVDR/MDR), including CE mark processStrong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstancesCertified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) - requiredThe 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 believe a diverse team builds more robust systems and achieves higher impact. We seek leaders who demonstrate curiosity, simplicity, composability, self‑service, and deep empathy toward colleagues, stakeholders, users, and patients.As set forth in Beacon Biosignals's Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.#J-18808-Ljbffr