System Engineering Manager

Purpose

The Systems Engineering Manager is responsible for leading the implementation, integration, and management of information technology infrastructure in accordance with organizational policies and industry best practices. This role oversees the development and operation of complex systems, ensuring reliability, security, and compliance with applicable regulations such as FDA 21 CFR Part 11. The ideal candidate is both a strategic thinker and a hands-on technical leader, capable of managing multiple projects and teams while maintaining operational excellence.

Responsibilities

• Implement and manage IT infrastructure aligned with organizational policies
• Monitor, alert, and troubleshoot all technology infrastructure
• Oversee the development of system architectures, requirements, and interface definitions
• Integrate hardware, software, and network components into cohesive systems
• Ensure designs meet engineering standards, industry best practices, and regulatory requirements
• Collaborate with project managers to plan, scope, and track technology deliverables
• Monitor technical progress, resolve issues, and maintain project timelines and budgets
• Act as the primary technical liaison between operations and external partners
• Communicate complex technical concepts in clear, actionable recommendations for executives and non-technical stakeholders
• Establish and maintain systems engineering processes, tools, and documentation standards
• Implement configuration management, verification/validation, and quality assurance practices
• Contribute to the development of the technology roadmap
• Secure and manage network infrastructure, including firewalls, switches, and wireless systems
• Manage shared and dedicated support teams
• Administer all technology systems across the organization

Skills

• Ability to work both independently and collaboratively
• Proven experience in medical device/technology and product development (required or highly preferred)
• Expertise in network engineering with Meraki, Cisco, and Fortinet technologies
• Experience with Microsoft 365, MDR, EDR, and SIEM platforms
• Proficiency in Azure, Nutanix, VMware, storage management, data integration, and data migrations
• Skilled in Single Sign-On, Entra ID, local Active Directory, server management, networking equipment, and data cabling standards
• Strong planning and organizational skills to maintain project discipline and accountability
• Familiarity with monitoring software such as LogicMonitor, SolarWinds, or equivalent
• Proficiency in Microsoft Office, Visio, and related productivity tools
• Ability to read, analyze, and interpret technical procedures and government regulations, including GxP standards
• Ability to obtain and maintain a favorable background investigation and security clearance

Qualifications/Requirements

• Bachelor’s degree in a related field (Engineering, Computer Science, or similar)
• Minimum of 7 years of experience in Systems Engineering
• Direct experience with GxP and FDA 21 CFR Part 11 compliance