Software Quality Engineer IV

About Beacon Biosignals

Join a pioneering team at the forefront of precision medicine for the brain. Beacon Biosignals is dedicated to transforming how neurological, psychiatric, and sleep disorders are treated by leveraging cutting-edge technology and data science. We are the leading provider of at-home EEG platforms for clinical development, empowering researchers and clinicians with unparalleled insights.

Our FDA 510(k)-cleared Dreem EEG headband and advanced AI algorithms are unlocking the power of quantitative biomarkers. With a vast Clinico-EEG database containing data from nearly 100,000 patients, our cloud-native analytics platform drives impactful large-scale RWD/RWE retrospective and predictive studies. At Beacon, you’ll be part of a mission to fundamentally change patient outcomes for conditions affecting brain physiology.

The Opportunity: Software Quality Partner

We are seeking a dedicated and pragmatic Software Quality Engineer to join our growing team. Reporting to the VP of Quality, this role offers significant growth potential within the Quality organization. You will act as a key Quality Partner, deeply embedded within our dynamic software and machine learning (ML) development squads. Your focus will be on supporting both the creation of exciting new products and the continued excellence of our existing platforms (sustaining engineering).

In this pivotal role, you will champion a compliant yet efficient approach, guiding teams to apply a “least-burdensome” development process that aligns seamlessly with Beacon’s ambitious goals and critical regulatory obligations. You will take ownership of shaping and enhancing our software compliance processes throughout the entire product lifecycle, from initial design and validation through release and essential post-market support.

What You’ll Do

Driving Quality & Compliance Excellence:

• Empower teams by providing comprehensive company-wide training on best practices in Software Development Lifecycle (SDLC) and risk management.
• Serve as a knowledgeable and confident representative for Beacon Biosignals during crucial second- and third-party audits and regulatory inspections.
• Stay ahead of the curve by tracking and interpreting evolving international regulatory standards, such as IEC 62304, translating complex requirements into actionable improvements for our processes and products.
• Oversee the thorough validation of software tools used across the organization, ensuring their fitness for intended use within a regulated environment.
• Facilitate smooth and compliant product releases by coordinating closely with our Software, Machine Learning (ML), and Manufacturing teams.
• Foster strong communication and strategic alignment across the broader Quality function and the entire organization.

How You’ll Thrive (Indicators of Success)

• Successfully contribute to company objectives by ensuring projects and medical device products are delivered efficiently, on time, within scope, and in full adherence to applicable regulatory and internal requirements.
• Provide practical, solutions-oriented guidance that empowers development teams to innovate rapidly without ever compromising on quality.
• Implement and evolve scalable quality processes that grow in sophistication alongside Beacon’s cutting-edge software and machine learning platforms.
• Proactively identify and strategically mitigate compliance risks before they impact project timelines or objectives.
• Build strong, trusting relationships and foster effective collaboration across diverse teams to ensure alignment and buy-in for quality initiatives.

What You’ll Bring

Required Qualifications:

• A minimum of 5 years of experience working hands-on in a software quality environment, specifically within the medical device industry.
• Proven ability to work effectively and autonomously, demonstrating strong analytical and problem-solving expertise.
• Demonstrated experience successfully implementing IEC 62304 requirements in practice.
• Holding a Certified Software Quality Engineer (CSQE) certification.
• Solid working knowledge of key industry standards and regulatory requirements, including 21 CFR Part 820, ISO 13485, and ISO 14971.
• A Bachelor’s degree in a relevant scientific, engineering, or related technical field.

Skills & Attributes:

• A strong intellectual curiosity and the ability to quickly understand complex technical concepts and contribute meaningfully to shaping the Quality team’s strategy.
• Exceptional interpersonal skills and relationship-building abilities, coupled with proven talent for managing projects and influencing decisions across multiple internal and external stakeholders.
• Excellent analytical, organizational, and communication skills, with a demonstrated capacity to adapt effectively to changing priorities and circumstances in a dynamic, fast-paced environment.

Work Environment

Beacon champions robust asynchronous work practices, ensuring a seamless and highly effective remote work experience for our team members located across the country. For those who prefer in-person collaboration, we also maintain office hubs available in Boston, MA and New York, NY.

Our Culture & Compensation

At Beacon Biosignals, we believe that cultural and scientific impact is best driven by individuals who lead through example. We actively seek contributors whose work reflects an avid curiosity, a bias towards simplicity in solutions, an eye for composability, a self-service mindset, and, above all, deep empathy towards colleagues, stakeholders, users, and the patients whose lives we strive to improve. We are committed to building a diverse team, knowing that varied perspectives lead to more robust systems and higher impact innovation.

The base salary range for this role is thoughtfully determined based on factors such as past experience, specific skills, and relevant qualifications. The base salary is an important component of our total compensation package, which also includes equity, generous Paid Time Off (PTO), and other competitive benefits.

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