The Quality Engineer III will guide hardware teams in new product development, ensure compliance, conduct audits, and oversee quality 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 in the Quality department will be reporting to the VP of quality and has growth potential to a management position. The position will be located in the US, preferably in or near a Beacon hub.
In this role, you’ll serve as a quality representative embedded within cross-functional squads, partnering closely with hardware engineering, manufacturing, and operations to support both new product development and sustaining initiatives. You’ll guide the evolution of our hardware quality systems across the entire product lifecycle—from design and manufacturing through product release and post-market activities. Acting as a subject matter expert, you’ll ensure our compliance efforts align with both internal standards and global regulatory requirements.
You’ll also play a key role in preparing for and leading second- and third-party audits, including regulatory inspections. Collaboration with our contract manufacturers will be essential, as you manage quality agreements, provide validation support, and maintain audit readiness. With a focus on continuous improvement, you’ll help shape quality processes that are both robust and efficient, always prioritizing a risk-based, least-burdensome approach to compliance.
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
- Delivering quality guidance that keeps programs moving efficiently and compliantly.
- Proactively identifying and resolving risks before they impact deliverables.
- Helping scale our hardware quality systems to meet the needs of a fast-growing hardware offerings.
- Building strong partnerships across engineering, operations, and clinical teams.
What you will bring:
- Minimum of 5 years of experience in a quality environment within the medical device industry
- Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
- Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE)
- Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, IEC 60601, and ISO 14971
- Experience working with electro-mechanical devices, including an understanding of general safety testing and performance testing
- Bachelor’s degree in a relevant scientific, engineering, or related field
- A strong intellectual curiosity with the ability to quickly grasp complex concepts, and solve problems.
- Exceptional interpersonal and relationship-building abilities
- 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
Iso 13485
Iso 14971
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