Systems 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 Systems Engineering Manager will report to the VP of R&D and lead the development of CoreMap's mapping system. This role combines people leadership with direct technical contribution and requires close collaboration with cross-functional partners including R&D, quality, regulatory, clinical and contract manufacturers. The Systems Engineering Manager will own CoreMap's system design activities from next-generation development through sustaining engineering, and regulatory submission support, 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 Systems Engineering team.
• 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 system projects status to the program management team and executive leadership.
• Partner with project managers and other stakeholders to define and implement system design improvement and sustaining projects.
• Ownership of system design documentation for software, hardware and catheter, to include Design Traceability Matrix, DFMEA, and complete Design History File and Device Master Record.
• Work closely with cross-functional teams, including software, hardware, quality, regulatory and clinical experts to ensure the mapping system meets performance requirements and is both effective and safe for patients.
• Partner with QA on the ownership of risk management files.
• Provide systems support to ongoing global clinical trials.
• Ensure all designs meet safety, performance and regulatory standards including 21 CFR Part 820, IEC 60601-1&2, ISO 13485 and ISO 14971 for the design, development and manufacturing of medical devices.
• Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes.

Skills and Experience

• B.S. or M.S. in a related Engineering discipline is required.
• Minimum of 2+ years of Medical Device team management experience.
• 6+ years of Medical Device systems engineering experience, ideally with cardiac devices
• Previous experience in EP is highly desired.
• Excellent verbal and written 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.

Salary range: $160,000 - $195,000

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