Catheter Engineering Manager

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 hands-on Catheter Engineering Manager will report to the VP of Engineering and lead the design, documentation, verification and sustaining of CoreMap’s EP mapping catheter. This role combines people leadership with direct technical contribution and requires close collaboration with cross-functional partners including R&D, manufacturing, quality, regulatory, supply chain and contract manufacturers. The Catheter Engineering Manager will own catheter design activities from next-generation development through sustaining engineering, supplier onboarding, and commercialization, ensuring performance, reliability, manufacturability, and regulatory compliance. This position is based full-time in our Burlington, MA office.

RESPONSIBILITIES

  • Technical and People leadership of the Catheter Engineering team in compliance with FDA Design Control regulations.

  • Act as a Company-wide advocate for compliance with all quality system and regulatory requirements.

  • Manage relationships with external partners to establish and report on goals, priorities and timelines.

  • Provide clear and timely communication of catheter projects status to the program management team and executive leadership.

  • Partner with project managers and other stakeholders to define and implement catheter design improvement and sustaining projects.

  • Ownership of catheter design documentation to include Design Traceability Matrix, DFMEA, and complete Design History File and Device Master Record.

  • Collaborate with contract manufacturers to define, develop, and execute Design Verification plans, protocols, and reports.

  • Partner with contract manufacturers to support manufacturability, process optimization, and cost reduction while maintaining quality and compliance.

  • Work closely with contract manufacturers and manufacturing operations team to remove manufacturing blockers and resolve technical issues.

  • Partner with QA on the ownership of risk management files.

  • Provide systems support to ongoing global clinical trials.

  • Ensure all designs meet safety, performance, biocompatibility, and regulatory standards including 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10555, ISO 11607, ISO 10993.

  • Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes.

SKILLS AND EXPERIENCE

  • BSc, MSc or PhD in Mechanical Engineering or a related discipline.

  • Minimum of 2+ years of Medical Device team management experience.

  • 6+ years of Medical Device development experience, ideally with cardiac devices.

  • Previous experience in EP is highly desired.

  • Experience in IP filing and patent protection.

  • Excellent verbal and writing communication skills.

  • Self-motivated team player.

  • Comfortable working in both a fast-paced and rigorous early-stage startup environment with fluid requirements, as well as a regulated later-stage process-driven setting.

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

Michelle DeJoie