ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
The Fountain Group
Burlington, MA, United States
This is an onsite role, remote work not possible. Pay $50-53/hour W2. W2 Candidates only for this role, C2C not possible. Description This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for softare utilized throughout Client. Develop and conduct training of compa
Job Source: The Fountain GroupState Street Corporation
Quincy, MA, United States
Who we are looking for We are currently looking for a talented Software Quality Engineer to perform manual testing for SQA efforts in Agile team(s) working to enhance State Street’s core asset servicing platform as well as run automation regression tests. This is an on-site location position for our Quincy, MA location. As a Software Quality En
Job Source: State Street CorporationVerily
Boston, MA, United States
Who We Are Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sourc
Job Source: VerilyGuardian Agriculture
Woburn, MA, United States
Guardian Agriculture develops large multicopters for applying agricultural chemicals to high-value crops. Our systems radically improve precision and safety relative to existing plane- and helicopter-based crop spraying solutions, while reducing chemical use, reducing impact on pollinating insects, and minimizing opportunities for organisms to acqu
Job Source: Guardian AgricultureVicarious Surgical
Waltham
Job Description Job Description As a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsible for quality system support for so
Job Source: Vicarious SurgicalVicarious Surgical
Waltham, MA, United States
As a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsible for quality system support for software R&D projects; generation an
Job Source: Vicarious SurgicalInstron
Norwood, MA, United States
Company Description Instron is a global organization that designs, manufactures, sells and services materials testing systems. Instron is a clear global leader in materials testing applications and its leadership in the marketplace is continually expanding. You will find that our established strength, commitment to our core values and team focus pr
Job Source: InstronInsight Global
Burlington, MA, United States
Job Description A global healthcare software client is looking for a Software Quality Engineer to join their team. This person will be embedded alongside developers, using their latest in-house automation framework in Java to create reliable and comprehensive automation tests. Teams rely on flexible but standardized processes to ensure test covera
Job Source: Insight GlobalBoston, MA, United States
Software Quality Engineer
Job Description
BrioHealth Solutions Inc., Inc. is seeking a Software Quality Engineer to support design quality efforts for an active implantable medical device, covering both clinical and commercial needs in a GMP environment. In this role, you will be involved in every stage of in the software development lifecycle, from requirements definition to post-market surveillance.
Responsibilities
Develop and execute comprehensive test plans to identify and mitigate software defects in Class III active implantable medical devices.
Lead and participate in test automation efforts to improve efficiency and coverage.
Collaborate with cross-functional teams including engineering, development, and regulatory affairs to ensure compliance with all relevant standards and regulations (e.g., FDA, ISO 13485).
Analyze test results, identify root causes of defects, and document corrective actions.
Participate in risk assessments and develop risk mitigation strategies for software.
Maintain a deep understanding of relevant medical device quality system regulations (QSRs) and standards.
Prepare, review, and maintain quality system documentation, including test plans, test cases, and reports.
Stay up to date on the latest advancements in medical device software testing.
Requirements
Minimum 5+ years of experience as a Software Quality Engineer in the medical device industry, with a strong focus on Class III active implantable devices.
Proven experience in developing and executing comprehensive test plans for medical device software.
In-depth knowledge of software development methodologies (e.g., Agile, Waterfall).
Experience with test automation tools and frameworks.
Strong understanding of risk management principles applied to medical device software.
Excellent analytical and problem-solving skills.
Superior written and verbal communication skills.
Ability to work independently and as part of a cross-functional team.
Familiarity with relevant medical device standards (e.g., IEC 62304, ISO 14971) is a plus.
Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE) is a plus.
Experience with implantable medical devices.
Knowledge of FDA IDE regulations.
Familiarity with FDA complaint handling procedures during an IDA and post PMA.
Experience with Six Sigma or other quality improvement methodologies.
About BrioHealth Solutions Inc
BrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe
#J-18808-Ljbffr
Software Quality Engineer jobs in Boston, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.