Quality Engineer IV

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.

Role

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. The role includes:

• SME for hardware and software compliance processes across design, manufacturing, product release, and post market support
• Leading and providing guidance to the Software, Machine Learning, and Hardware teams for new product development and sustaining engineering to support Beacon goals, collaborating closely with engineering leadership.
• Improving processes for compliance, implementing the least burdensome approach
• Representing Beacon in second (customer) and third party audits (ISO auditors) as well as inspections by regulators as the SME in relevant areas.
• 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
• Coordinating product releases in collaboration with Software, Machine Learning, and manufacturing teams
• Coordinate Product Releases: Collaborate with engineering and machine learning teams to plan, execute, and document product releases.
• Support Product Development Teams: Provide expertise in the design of regulated products, ensuring compliance with quality standards.
• Consult Across Teams: Act as a quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control.
• Ensure Timely Project Delivery: Drive efforts to ensure projects are completed on time, within scope, and in compliance with all regulatory requirements.
  
  
  

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 and initiatives to ensure projects and products are completed on time, within scope, and in compliance with all applicable regulatory and company requirements.

What You Will Bring

• Minimum of 8 years of software 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
• Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, IEC 60601, IEC 80601, TIR45, and ISO 14971
• Bachelor’s degree in a relevant scientific, engineering, or related field
• Demonstrated experience implementing IEC 62304
• 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
• Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE), preferred but not required
• Knowledge of European regulatory requirements such as IVDR or MDR, including CE mark process
  
  
  

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.