Job Description
Senior Quality Engineer at CoreMap Senior Quality Engineer at CoreMap in Winchester, Massachusetts Posted in 14 days ago.
Type:
full-time Job Description:
CoreMap's mission is to improve the lives of people affected by atrial fibrillation. We are developing a highresolution, real-time, 3D electroanatomical mapping system for use during cardiac procedures to guide ablation therapy. Our system will generate novel maps of AF using advanced statistical analysis of data acquired from our ultra high-resolution cardiac catheter. The Senior Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment. This role is based full time in our Burlington, MA office. RESPONSIBILITIES
Lead support for new product development and product realization through design control phase activity including development, verification, validation, transfer, and associated design reviews for software/data science, hardware/systems, and catheter engineering Lead support for sustaining engineering through operational quality activity - material control, inspection/acceptance activity, nonconforming material control, equipment qualification, supplier management, CAPA, and clinical operations including handling and control of protected health information Lead support for software design, development, risk analysis, qualification, and version release activity and applicable documentation deliverables, including cybersecurity Lead risk management activity - analysis and documentation applied throughout the product development process Inspect and test materials, equipment, processes, and products to ensure quality specifications are met Lead support for test method development and qualification activity Lead support for the design engineering teams for catheter, hardware, software and systems throughout the design control process Lead the design, implementation, and maintenance of quality system processes to comply with regulatory standards Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes SKILLS AND EXPERIENCE
Degree in mechanical or biomedical engineering or related applicable engineering field Minimum of 8 years of experience in quality engineering or a related role in a regulated industry Experience in catheter, hardware, software and system design and development, or with similar medical devices, while working 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, good documentation practices (formal protocols and reports), attention to detail, and project management skills
