Beacon Biosignals, Inc.
Quality Engineer IV New Boston, MA - Remote
Beacon Biosignals, Inc., Boston, Massachusetts, us, 02298
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 report 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:
Responsibilities
SME for hardware and software compliance processes across design, manufacturing, product release, and post‑market support.
Lead and provide 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.
Improve processes for compliance, implementing the least burdensome approach.
Represent Beacon in second (customer) and third‑party audits (ISO auditors) as well as inspections by regulators as the SME in relevant areas.
Stay current on changes to international standards and regulations, communicating insights and awareness to the broader organization.
Collaborate and align within the quality team and across the company.
Coordinate product releases in collaboration with Software, Machine Learning, and manufacturing teams.
Act as a quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control.
Drive efforts to ensure projects are completed on time, within scope, and in compliance with all regulatory requirements.
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.
Salary & Benefits 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.
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.
EEO Statement As set forth in Beacon Biosignals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. We do not discriminate on the basis of protected veteran status. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.
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This role in the Quality department will report 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:
Responsibilities
SME for hardware and software compliance processes across design, manufacturing, product release, and post‑market support.
Lead and provide 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.
Improve processes for compliance, implementing the least burdensome approach.
Represent Beacon in second (customer) and third‑party audits (ISO auditors) as well as inspections by regulators as the SME in relevant areas.
Stay current on changes to international standards and regulations, communicating insights and awareness to the broader organization.
Collaborate and align within the quality team and across the company.
Coordinate product releases in collaboration with Software, Machine Learning, and manufacturing teams.
Act as a quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control.
Drive efforts to ensure projects are completed on time, within scope, and in compliance with all regulatory requirements.
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.
Salary & Benefits 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.
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.
EEO Statement As set forth in Beacon Biosignals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. We do not discriminate on the basis of protected veteran status. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.
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