ClinLab Solutions Group
Senior Quality Engineer at ClinLab 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 - $140,000.00/yr Responsibilities
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. Skills and Experience
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.
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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 - $140,000.00/yr Responsibilities
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. Skills and Experience
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.
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