Sr. Systems Engineer

Position Overview

Join a growing medical device company developing innovative vascular technologies that improve patient care. We are seeking a Senior Systems Engineer to lead product development from concept through commercialization, driving system design, design controls, risk management, and verification & validation (V&V) in a collaborative, cross-functional environment.

Key Responsibilities

• Lead system design and product development activities from concept through commercialization.
• Own design controls, risk management, and system-level V&V.
• Develop test strategies, protocols, reports, and technical documentation to support regulatory submissions.
• Provide technical leadership to internal teams and external engineering partners.
• Collaborate with Engineering, Quality, Regulatory, Manufacturing, and Clinical teams.
• Drive improvements in product performance, reliability, and manufacturability.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical, Software Engineering, or a related field (Master's preferred).
• 7+ years of medical device product development experience in an FDA-regulated environment.
• Strong expertise in design controls, risk management, and verification & validation.
• Experience working across mechanical, electrical, and software systems.
• Excellent leadership, communication, and problem-solving skills.

Preferred Qualifications

• Startup or early-stage medical device experience.
• Experience with cardiac monitoring, ECG, electrophysiology, or catheter-based technologies.
• Knowledge of FDA Design Controls, ISO 14971, IEC 60601, and other applicable medical device standards.