Quality Engineer II

CoreMap’s mission is to enable a cure for the millions of patients suffering with atrial fibrillation (AF). 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 Quality Engineer II 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

  • Support 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

  • Support 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

  • Support software design, development, risk analysis, qualification, and version release activity and applicable documentation deliverables, including cybersecurity

  • Participate in 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

  • Support test method development and qualification activity

  • Support the 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 an unwavering focus on advancing patient outcomes

SKILLS AND EXPERIENCE

  • Degree in mechanical or biomedical engineering or related applicable engineering field

  • Minimum of 5 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

For inquiries or to submit your resume, email us at jobs@coremapmedical.com and reference the job posting in your email title.

Michelle DeJoie