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 Dreem 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 role will be reporting to the VP of Quality and has growth potential within the Quality organization. In this role, you’ll serve as a quality partner embedded within squads focused on software and machine learning, supporting both new product development and sustaining engineering. You’ll guide these teams in applying a compliant, least-burdensome approach to development, while aligning with Beacon’s broader goals and regulatory obligations. You’ll take the lead in maintaining and evolving software compliance processes across the product lifecycle—from design and validation through release and post-market support.

 

You’ll provide company-wide training on software development lifecycle (SDLC) practices and risk management, and will represent Beacon in second- and third-party audits, including inspections. You’ll be responsible for keeping pace with international regulatory and standards changes—such as IEC 62304—and translating that knowledge into actionable improvements. You’ll also oversee validation of software tools and coordinate product releases in collaboration with Software, Machine Learning, and Manufacturing teams. In addition, you’ll foster alignment and communication across the broader Quality function and the organization as a whole.

 

Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston and New York.