Quality Engineer

Senior Quality Engineer at Clin Lab Staffing

We are developing a high-resolution, real-time, 3D electroanatomical mapping system that will be used during cardiac electrophysiology (EP) procedures to generate novel maps of AF using data acquired from an ultra–high-resolution catheter. The Sr. Quality Engineer will support sustaining engineering and new product development activities for the Quality Assurance department in a dynamic and complex engineering environment. This role is based full time in our Burlington, MA office.

Base pay range: $90,000.00/yr - $/yr

• Support new product development and product realization through design control activities, including development, verification, validation, transfer, and associated design reviews for software/data science, hardware/systems, and catheter engineering.
• Support sustaining engineering through operational quality activities—material control, inspection/acceptance activities, nonconforming material control, equipment qualification, supplier management, CAPA, and clinical operations, including handling and control of protected health information.
• Support software design, development, risk analysis, qualification, version release activities, and applicable documentation deliverables, including cybersecurity.
• Participate in risk management activities, including analysis and documentation throughout the product development process.
• Inspect and test materials, equipment, processes, and products to ensure quality specifications are met.
• Support test method development and qualification activities.
• Support design engineering teams for catheter, hardware, software, and systems throughout the design control process.
• Design and implement quality system processes to comply with regulatory standards.
• Foster a culture of trust, open communication, and continuous improvement, with a strong focus on advancing patient outcomes.

• Degree in mechanical or biomedical engineering or a related engineering field.
• Minimum of 8 years of experience in quality engineering or a related role within a regulated industry.
• Experience in catheter, hardware, software, and system design and development—or similar medical devices—within a Quality Management System.
• Applied understanding of 21 CFR 820, ISO 13485:2016, ISO 14971:2019, IEC 60601-1:2020, IEC 62304:2006, GDPR, and HIPAA regulations.
• Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods.
• Experience in risk management and design control.
• Excellent communication skills, strong documentation practices (formal protocols and reports), attention to detail, and project management skills.