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Quality Engineer IV

Boston, MA - Remote

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. The role includes:

  • Leading and providing guidance to the Hardware and Software teams for new product development and sustaining engineering to support Beacon goals.
  • SME for 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.
  • Leading and providing guidance to the Software and Machine Learning teams for new product development and sustaining engineering to support Beacon goals.
  • Representing the quality team on squads to support tactical work
  • Improving processes for compliance, implementing the least burdensome approach
  • Providing company-wide training on SDLC and Risk Management
  • 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 align 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

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 5 years of software and hardware 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, 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), desired but not required

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.

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