Full-Time
Quality Engineer
Quality, Diagnostics
Posted on 8/9/2025
Beacon Biosignals
51-200 employees
EEG neurobiomarker platform for trials
No salary listed
Cleveland, OH, USA
In Person
 QA & Testing (1) |
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- Minimum of 7 years of hardware experience in a manufacturing quality environment within the medical device industry
- Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
- Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, IEC 60601, IEC 80601, 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
- Leading and providing guidance to the Diagnostics team for new product development and sustaining engineering to support Beacon goals
- Supporting hardware and software compliance processes across design, manufacturing, product release, and post market support
- Oversight of contract manufacturing facilities, including quality agreements, validation support, and periodic audits
- Representing the quality team on squads to support tactical work
- Improving processes for compliance, implementing the least burdensome approach
- Representing Beacon in second and third party audits as well as inspections
- Staying current on changes to international standards and regulations, communicating insights and awareness to broader organization
- Collaborating and aligning within the quality team and across the company
- Oversight of the validation of software tools to meet regulatory and operational standards
- Coordinating product releases in collaboration with Software, Machine Learning, and manufacturing teams
- Leading post market surveillance, including customer complaint analysis to improve product reliability and performance
- Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE), desired but not required
Beacon Biosignals develops an EEG-based neurobiomarker platform for precision medicine in neurology and psychiatry. Its core offering provides quantitative assessments of how treatments affect EEG and sleep data to speed up clinical trials and inform dose selection. By analyzing EEG signals alongside PK/PD relationships, the platform helps identify dosing that achieves the best balance of efficacy and safety, supporting the development of new therapies. The company differentiates itself through its proprietary EEG biomarkers and a focus on integrating brain activity data into trial design, enabling closer monitoring of treatment impact for biopharma, academic medical centers, and neurotechnology developers. Beacon Biosignals aims to advance personalized treatment for neurological and psychiatric diseases and improve the efficiency of clinical development in precision medicine.
Company Size
51-200
Company Stage
Series B
Total Funding
$127.5M
Headquarters
Boston, Massachusetts
Founded
2019
Simplify's Take
What believers are saying
- Series B upsized to $97M in April 2026 funds largest neurodiagnostic dataset.
- CleveMed acquisition adds airflow and oxygen metrics to EEG platform.
- Skye Bioscience collaboration integrates sleep endpoints in Nimacimab Phase 2 trial.
What critics are saying
- Nocturnal's nPDRX multi-channel EEG headband steals biopharma clients within 6 months.
- CerebraAI's superior model on 500K EEG hours defects Takeda in 12 months.
- MIT's open-source 1M-hour EEG model enables in-house biopharma analytics by 2027.
What makes Beacon Biosignals unique
- Beacon's Waveband captures FDA-cleared home EEG during sleep and wake.
- Two 2024 FDA PCCP authorizations enable agile ML updates for EEG analytics.
- Beacon Platform trains foundation model on millions of EEG hours for biomarkers.
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Benefits
Company Equity
Paid Vacation
Hybrid Work Options
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↓ -1%2 year growth
↓ -4%Beacon Biosignals targets neurology trial partners with fda-cleared Waveband EEG at AAN 2026. Last updated: April 20, 2026 Beacon Biosignals is participating in the 2026 American Academy of Neurology Annual Meeting in Chicago. The company is showcasing its Waveband device, a novel technology for electroencephalogram (EEG) signal acquisition and analysis. This event marks a significant opportunity for the company to present its advancements in brain signal technology to a key audience of neurologists and researchers. * Beacon Biosignals' Waveband device is designed for advanced EEG signal acquisition and analysis. The device aims to provide more accurate and efficient data collection for neurological studies. The company's presence at the American Academy of Neurology Annual Meeting signifies its commitment to developing and promoting innovative solutions in the field of neurology. This participation allows for direct engagement with medical professionals and potential collaborators. The meeting is a premier event for showcasing the latest research and technologies in neurology.
Beacon Biosignals has extended its Series B financing to $97 million, bringing total funding to over $132 million. The upsized round includes new investors JSL Health, Palo Santo VC, Kicker Ventures and Samsung Next. The Boston-based company combines FDA-cleared wearable EEG technology with AI to capture and analyse brain data for neurology, psychiatry and sleep medicine applications. The additional capital will accelerate Beacon's development of at-home EEG and advanced analytics for diagnostics, clinical trials and precision medicine. The original $86 million Series B was led by healthcare and technology investors including Innoviva, GV, S32, Catalio Capital Management, General Catalyst, Logos Capital, Casdin Capital and Indicator Ventures. The platform provides clinicians and biopharma partners with objective measures of brain function.
Beacon Biosignals upsizes Series B financing to over $97 million. GlobeNewswire | Beacon Biosignals Today at 3:30am PDT BOSTON, April 06, 2026 (GLOBE NEWSWIRE) - Beacon Biosignals today announced an extension to its Series B financing, bringing the funding round to $97 million and the company's cumulative funding to over $132 million. The upsized round includes new investors JSL Health, Palo Santo VC, Kicker Ventures, and Samsung Next. This financing builds on Beacon's previously announced $86 million Series B, led by a syndicate of leading healthcare and technology investors, including Innoviva, GV (Google Ventures), S32, Catalio Capital Management, General Catalyst, Logos Capital, Casdin Capital, Indicator Ventures and others. The new capital will further accelerate Beacon's mission to transform brain health through scalable, at-home EEG and advanced analytics, powering the next generation of diagnostics, clinical trials, and precision medicine. "This milestone reflects strong momentum behind our vision to make brain health measurable, scalable, and actionable," said Jacob Donoghue, CEO of Beacon Biosignals. "We're grateful for the support of our new and existing investors as we build the future of brain health." "Beacon is uniquely positioned to unlock the potential of brain data at scale," said Daniel Goldberg, Managing Director at Palo Santo. "Their combination of clinical-grade EEG and advanced analytics is enabling a new era of discovery and precision in neuroscience. As novel therapeutics like psychedelics reshape the treatment landscape for psychiatric disease, platforms like Beacon's will be critical for objectively measuring brain-based outcomes and accelerating development." About Beacon Biosignals Beacon Biosignals is unlocking the power of brain data to advance human health. The company combines FDA-cleared wearable EEG technology with advanced AI to capture and analyze real-world neural data, enabling breakthroughs across neurology, psychiatry, and sleep medicine. The Beacon Platform provides clinicians and biopharma partners with objective measures of brain function that accelerate research, improve diagnostics, and guide new treatments. Learn more at www.beacon.bio. Media Contact: Isabella Lazzareschi, Beacon Biosignals [email protected] This is a paid placement. For further inquiries, please contact GlobeNewswire directly.
citybiz+ neurotechnology startup Beacon Biosignals closes $86M Series B. New York-based Catalio Capital Management, an investment firm started in Baltimore, has joined an $86 million Series B for Boston-based Beacon Biosignals, a neurotechnology company powering AI-driven diagnostics and precision medicines for the brain. Other investors included Innoviva, Google Ventures (GV), Nexus NeuroTech Ventures, S32 and Takeda. Existing investors who participated included General Catalyst, Miami, Fla.-based Logos Capital, Casdin Capital and Indicator Ventures. Beacon has raised more than $121 million so far. It plans to use the recent funding to build the world's largest neurodiagnostic dataset and advance the clinical application of AI-driven biomarkers for brain health. "Our mission is to make brain function measurable and actionable at scale," said Jacob Donoghue, MD, PhD, CEO and co-founder of Beacon Biosignals. "By training AI on millions of hours of real-world brain data, we're beginning to map the signals of health and disease in ways that can accelerate drug development." Unlike consumer wearables that infer brain activity indirectly, Beacon Biosignals says, the company's FDA-cleared Waveband device directly measures the brain's electrical activity (EEG) during sleep and wake, bringing "gold-standard neurophysiology out of the lab and into patients' homes." Beacon Biosignals' partners include companies such as Takeda, UCB, Mineralys and Syndeio. The company recently acquired CleveMed's home sleep-testing technology, helping expand its platform to include airflow, respiratory effort and oxygen saturation, in addition to EEG. Catalio was spun out of investment firm Camden Partners in 2020 by Johns Hopkins alumni George Petrocheilos and R. Jacob Vogelstein, the son of famed geneticist Bert. Initially established in Baltimore, the healthcare- and life sciences-focused firm sold a minority stake to investment powerhouse KKR in 2023, and named Kravis, co-founder and co-executive chairman of KKR, as chairman of its board of advisers. Its other big-name investors include Philippe Laffont, the billionaire founder of hedge fund Coatue Management and the father of a classmate of Petrocheilos and Vogelstein, Thoma Bravo, Brevan Howard and Stanley Druckenmiller. Petrocheilos has degrees from Harvard and Johns Hopkins, and previously ran HealthCor and Global Domain hedge fund. Vogelstein, who worked with Petrocheilos at Camden, served on the faculty at Johns Hopkins University - at both the Applied Physics Laboratory and the Whiting School of Engineering. Vogelstein, who worked with Petrocheilos at Camden, served on the faculty at Johns Hopkins University - at both the Applied Physics Laboratory and the Whiting School of Engineering. Catalio boasts of partnerships with 36 world-renowned scientists, each of whom is also an entrepreneur. Its portfolio investments include Perceive Pharma, Aviceda Therapeutics, Alentis Therapeutics, Orantis and Superluminal Medi.
Beacon's 86$ million Series B funding will expand its precision medicine platform, unlocking treatments for neurological and psychiatric disease....