Full Time: Systems Engineering Senior

Senior Systems Engineer

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.

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.

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.

S. in a related Engineering discipline is required.

• 5+ years working in medical device development with 3+ years in systems engineering experience is required.
• Significant experience with systems incorporating complex algorithms, hardware and software is preferred.