Quality Engineer for Software and Machine Learning in Medical Devices - Remote

Overview

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.

In Short

• Reporting to the VP of Quality with growth potential within the Quality organization.
• Serve as a quality partner embedded within squads focused on software and machine learning.
• Guide teams in applying compliant development approaches.
• Maintain and evolve software compliance processes across the product lifecycle.
• Provide company-wide training on SDLC practices and risk management.
• Represent Beacon in second- and third-party audits.
• Oversee validation of software tools and coordinate product releases.
• Keep pace with international regulatory and standards changes.
• Foster alignment and communication across the Quality function.
• Drive scalable quality processes that evolve with Beacon’s platforms.

Requirements

• Minimum of 5 years of experience in a software quality environment within the medical device industry.
• Proven ability to work autonomously with strong analytical skills.
• Demonstrated experience implementing IEC 62304.
• Certified software quality engineer (CSQE).
• Working knowledge of industry standards and regulations like 21CFR 820.
• Bachelor’s degree in a relevant scientific or engineering field.
• Exceptional interpersonal and relationship-building abilities.
• Strong organizational and communication skills.

Benefits

• Equity and PTO included in the total compensation package.
• Opportunity to work in a dynamic and impactful environment.
• First-class remote work experience with in-person office hubs available.
• Cultural and scientific impact driven by diverse team contributions.