Lead software quality initiatives, ensuring compliance with standards in medical device development, while collaborating across teams and improving processes.
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.
What success looks like
- Supporting company goals by ensuring projects and products are delivered on time, within scope, and in full compliance with applicable regulatory and internal requirements
- Providing pragmatic, solutions-oriented guidance that enables teams to move quickly without sacrificing quality
- Driving scalable quality processes that evolve with Beacon’s software and machine learning platforms
- Anticipating and mitigating compliance risks before they become roadblocks
- Collaborating effectively across teams to build trust and alignment around quality initiatives
What you will bring
- Minimum of 5 years of experience in a software quality environment within the medical device industry
- Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
- Demonstrated experience implementing IEC 62304
- Certified software quality engineer (CSQE)
- Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, and ISO 14971
- Bachelor’s degree in a relevant scientific, engineering, or related field
- A strong intellectual curiosity with the ability to quickly grasp complex concepts, contribute to shaping the quality team, and thrive in a dynamic space.
- Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders.
- Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances
The base salary range for this role is determined based on past experience, specific skills and qualifications. 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.
Top Skills
21Cfr 820
Iec 62304
Iso 13485
Iso 14971
Beacon Biosignals Boston, Massachusetts, USA Office
Boston, MA, United States
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