Back to jobs

Software 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 will be reporting to the VP of Quality and has growth potential within the Quality organization. In this role, you’ll serve as a quality partner embedded within squads focused on software and machine learning, supporting both new product development and sustaining engineering. You’ll guide these teams in applying a compliant, least-burdensome approach to development, while aligning with Beacon’s broader goals and regulatory obligations. You’ll take the lead in maintaining and evolving software compliance processes across the product lifecycle—from design and validation through release and post-market support.
 
You’ll provide company-wide training on software development lifecycle (SDLC) practices and risk management, and will represent Beacon in second- and third-party audits, including inspections. You’ll be responsible for keeping pace with international regulatory and standards changes—such as IEC 62304—and translating that knowledge into actionable improvements. You’ll also oversee validation of software tools and coordinate product releases in collaboration with Software, Machine Learning, and Manufacturing teams. In addition, you’ll foster alignment and communication across the broader Quality function and the organization as a whole.
 
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 by ensuring projects and products are delivered on time, within scope, and in full compliance with applicable regulatory and internal requirements
  • Providing pragmatic, solutions-oriented guidance that enables teams to move quickly without sacrificing quality
  • Driving scalable quality processes that evolve with Beacon’s software and machine learning platforms
  • Anticipating and mitigating compliance risks before they become roadblocks
  • Collaborating effectively across teams to build trust and alignment around quality initiatives
What you will bring:
  • Minimum of 5 years of experience in a software quality environment within the medical device industry
  • Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
  • Demonstrated experience implementing IEC 62304
  • Certified software quality engineer (CSQE)
  • Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, 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
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.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

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.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.