Director, Systems Engineering

This role will lead technical initiatives focused on scalable systems, platform reliability, and meaningful business transformation within the healthcare space. You will work across engineering, product, operations, and business stakeholders to translate complex requirements into practical technology solutions.

Responsibilities

• Lead and mentor Systems Engineering and Test teams in cardiac diagnostic product development
• Own and execute functional strategy and resource planning for Systems Engineering
• Drive adoption of improved engineering processes and maintain team compliance standards
• Manage system-level requirements ensuring clear, traceable product needs
• Communicate project status and execution priorities to executive leadership
• Support vendor partnerships and engineering evaluations for design changes
• Collaborate across functions to meet regulatory and business needs

Qualifications

• BS in Systems Engineering, Electrical Engineering, Biomedical Engineering, or related degree; MS/MBA preferred
• 15+ years in regulated medical device development, particularly Class II/III Connected
• 8+ years of leadership experience managing multidisciplinary engineering teams
• Expertise in systems engineering practices including requirements traceability and configuration management
• Experience in developing hardware and software interfaces for medical devices
• Working knowledge of FDA QMSR/21 CFR Part 820, ISO 13485, and related standards
• Proven skills in risk management and design change execution

Benefits

• Flexible work environment with options for remote and hybrid arrangements
• Opportunities for professional development and certification
• Engagement with a community of practice for Systems Engineering
• Involvement in QMS improvement initiatives for improved processes
• Potential travel opportunities within the U.S. for collaboration and partnerships

Pay

$182,000 – $237,000 annually

Location: Remote - US based candidates only, no visa sponsorship available