Senior System Engineer

CoreMap’s mission is to improve the lives of people affected by atrial fibrillation. We are

developing a high-resolution, 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 Systems Engineer will report to the Systems Engineering Manager and work

cross functionally on the development of CoreMap’s mapping system. This role includes the

design, development and verification of the mapping system from prototype to commercial

release. This role is based full-time in our Burlington, MA office.

Responsibilities

• 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.
• Define system architecture and requirements for CoreMap mapping system, including integration with catheters, signal acquisition hardware, software, and user interfaces.
• Create and maintain design trace matrices for software, hardware and catheter to ensure the design outputs meet design inputs.
• Plan and execute Design Verification (DV) testing with accurate and timely documentation in Design Verification Protocols and Reports.
• Ensure accurate and timely documentation of objective evidence in the Design History File, Device Master Record and Device History Record.
• Lead system prototype development and testing to evaluate new designs.
• Implement systems engineering methodologies to support development (e.g., DFMEA, Risk Assessment, Design Reviews).
• Partner with contract design and manufacturing organizations to support future system design definitions and implementation.
• 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.
• Partner with QA on the ownership of risk management files.
• Provide systems support to ongoing global clinical trials.
• 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.
• 5+ years working in medical device development with 3+ years in systems engineering experience is required.
• Previous experience in EP is highly desired.
• Significant experience with systems incorporating complex algorithms, hardware and software is preferred.
• Excellent verbal and written communication skills.
• 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.