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Senior Design Quality Engineer

Senior Design Quality Engineer

BRIOHEALTH SOLUTIONS INCBurlington, MA, US
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Job Description

Job Description

About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

BrioHealth Solutions is seeking a Senior Design Quality Engineer to drive quality assurance compliance for our implantable medical devices, supporting both clinical and commercial operations. In this role, you will lead complaint handling, root cause analysis, FDA reporting, and returned product investigations, ensuring continuous improvement in product safety and performance. This is a high-impact role where your expertise will directly contribute to enhancing product quality, optimizing failure analysis processes, and ensuring regulatory compliance.

Responsibilities

Complaint Investigation & Product Analysis

  • Lead device history reviews, returned product evaluations, and failure investigations to determine root causes.
  • Conduct visual and functional inspections of returned devices and peripherals.
  • Collaborate with engineering, manufacturing, and R&D teams to identify and implement corrective actions.
  • Develop and refine inspection, testing, and evaluation methodologies for returned products.
  • Author comprehensive technical reports documenting findings, root causes, and CAPA (Corrective and Preventive Action) recommendations.

Regulatory Compliance & Reporting

  • Ensure compliance with FDA QSR, ISO 13485, and global regulatory requirements for complaint investigations.
  • Support complaint investigation processes during regulatory audits and inspections.
  • Maintain knowledge of OSHA and CDC regulations for handling potentially biohazardous materials.
  • Support regulatory reporting requirements related to FDA IDE regulations and post-PMA complaint handling.

    • Quality Management & Continuous Improvement

  • Drive continuous improvement initiatives in complaint handling and returned product analysis.
  • Participate in process enhancements, including updating SOPs, refining metrics, and supporting change requests.
  • Work closely with key quality and business stakeholders to ensure comprehensive product investigations.
  • Stay current on industry standards and emerging best practices for medical device quality engineering.

    • Additional Responsibilities

  • Log, track, and manage returned devices and peripherals.
  • Perform failure analysis investigations using advanced techniques.
  • Develop and implement preventive actions to minimize recurrence of product issues.

    • Qualifications

  • Bachelor’s degree in Engineering, Science, or a related field.
  • 7+ years of experience in a medical device quality engineering role.
  • Hands-on experience with failure analysis techniques for medical devices.
  • Strong understanding of risk management principles and regulatory requirements (FDA QSR, ISO 13485).
  • Experience with implantable medical devices and complaint handling during IDE and post-PMA phases.
  • Knowledge of FDA regulatory processes, including complaint handling and CAPA methodologies.
  • Strong analytical, problem-solving, and technical writing skills.
  • Ability to work independently while effectively collaborating with cross-functional teams.
  • Experience with Six Sigma or other quality improvement methodologies is a plus.
  • Must be able to maintain up-to-date biohazardous material vaccinations (Hepatitis A, B, C, etc.), as required.
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