Overview
Senior Design Quality Engineer Jobs in Burlington, Vermont, USA at BrioHealth Solutions
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We are a global team of Med-Tech professionals focused on patient-centric solutions, developing advanced heart failure therapy technology with the BrioVAD LVAS. We aim to improve patient outcomes and expand access to chronic MCS therapy worldwide.
Job Summary
Brio Health Solutions seeks a Returned Product Analysis (RPA) Quality Engineer to ensure quality assurance compliance for our implantable medical devices, supporting clinical and commercial operations. You will lead complaint handling, root cause analysis, FDA reporting, and product investigations, contributing to product safety, performance, and regulatory compliance.
Responsibilities
Lead device history reviews, returned product evaluations, and failure investigations to identify root causes.
Perform visual and functional inspections of returned devices and peripherals.
Collaborate with engineering, manufacturing, and R&D teams to implement corrective actions.
Develop and improve inspection, testing, and evaluation methods for returned products.
Document findings, root causes, and CAPA recommendations in technical reports.
Regulatory Compliance & Reporting
Ensure compliance with FDA QSR, ISO 13485, and other global regulations for complaint investigations.
Support complaint investigations during audits and inspections.
Maintain knowledge of OSHA and CDC regulations for handling biohazardous materials.
Support regulatory reporting related to FDA IDE and post-PMA complaints.
Quality Management & Continuous Improvement
Drive improvements in complaint handling and product analysis processes.
Participate in SOP updates, metric refinement, and change management.
Work with quality and business stakeholders to ensure thorough investigations.
Stay informed on industry standards and best practices in medical device quality engineering.
Additional Responsibilities
Log, track, and manage returned devices and peripherals.
Conduct failure analysis using advanced techniques.
Develop preventive actions to reduce recurrence of issues.
Qualifications
Bachelor’s degree in Engineering, Science, or related field.
At least 2 years of experience in medical device quality engineering.
Hands-on failure analysis experience for medical devices.
Understanding of risk management and regulatory requirements (FDA QSR, ISO 13485).
Experience with implantable medical devices and complaint handling during IDE and post-PMA phases.
Knowledge of FDA processes, CAPA, and regulatory reporting.
Strong analytical, problem-solving, and technical writing skills.
Ability to work independently and collaboratively.
Experience with Six Sigma or similar methodologies is a plus.
Up-to-date biohazard vaccinations required.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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Title: Senior Design Quality Engineer
Company: BrioHealth Solutions
Location: Burlington, Vermont, USA
Category: Engineering (Quality Engineering, Biomedical Engineer), Quality Assurance – QA/QC (Quality Engineering)
