IT Manager

Description:

SetPoint Medical’s IT Manager owns the company’s IT infrastructure, end-user technology, and IT support services, and leads the deployment of high-value AI solutions across business operations. The role establishes and enforces cybersecurity and technology controls, supports audit readiness in a regulated environment, and ensures employees have reliable, secure, scalable access to the technology they need.

The IT Manager leads SetPoint’s IT function, with direct responsibility for IT Specialists as well as IT consultants and contractors, while personally scoping, building, and deploying AI workflows with functional owners in Quality, Manufacturing/Supply Chain, and Commercial. Success in this fast-paced start-up environment requires strong communication, composure under pressure, ownership of tasks from start to finish, and effective cross-functional collaboration.

Requirements:

IT Operations & Infrastructure

• Own day-to-day IT operations and non-product IT infrastructure: networks, endpoints, identity and access management, Microsoft 365, cloud services, and collaboration tools.
• Manage employee technology onboarding and offboarding, including user accounts, access permissions, hardware provisioning, and equipment recovery.
• Establish and maintain IT standards, procedures, and documentation, including business continuity, disaster recovery, backup, and IT incident response plans.
• Data driven approach for managing IT & Cyber performance, maintaining KPIs that will be shared with the management team and the board.

Security & Compliance

• Own enterprise security posture: security awareness training, phishing prevention, patching, MFA, endpoint protection, and incident response.
• Own the non-product software (NPS) program: inventory, risk classification, and lifecycle status for all software supporting quality, manufacturing, and business processes.
• Plan and execute computer system validation per 21 CFR Part 11 and ISO 13485: intended use definition, risk assessment, validation protocols/reports, and periodic review.
• Support compliance and audit readiness (e.g., HITRUST controls, customer security questionnaires, HIPAA data handling, FDA cybersecurity expectations for connected systems).

Team Vendors & Budget

• Directly supervise and develop IT Specialists: hiring, onboarding, goal setting, regular 1:1s, performance reviews, development planning, timekeeping and overtime approval, and coverage planning for support continuity.
• Manage, develop, and set priorities for the IT support desk; define SLAs and track service quality.
• Direct IT consultants and contractors: statements of work, deliverables, budgets, and performance.
• Own the internal IT budget: annual planning, hardware and non-product software purchases, licensing and renewals, asset inventory, technology lifecycle, and vendor contracts.

Business Systems

• Scope, build, and deploy IT workflows with functional owners; train employees on approved tools, drive adoption, and maintain an IT roadmap tied to business outcomes.
• Support selection, configuration, validation, vendor management, and rollout of business systems (e.g., ERP/MRP, QMS/eQMS, CRM, HRIS integrations).
• Identify opportunities to automate routine activities and improve IT processes and the overall end-user technology experience.

Minimum Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, or equivalent practical experience.
• 7+ years in IT roles, including at least 2 years directly supervising employees (performance management and development), and experience managing contractors or an IT service function.
• Working knowledge of enterprise security fundamentals (identity/access, endpoint protection, incident response) and experience implementing security controls.
• Experience administering or implementing business systems such as ERP/MRP, QMS, or CRM platforms.
• Strong communication skills; able to translate between executives, functional owners, and technical vendors.
• Experience in medical device, pharma, or another regulated industry (21 CFR Part 11, computer system validation, ISO 13485 environments).
• Experience managing IT vendors, software licensing, hardware procurement, technology budgets, asset lifecycle management, business continuity, disaster recovery, backups, and IT operational procedures.
• Security or IT certifications (e.g., CISSP, CISM, etc) is a plus.
• Experience with AI governance frameworks (e.g., NIST AI RMF) and vendor security assessments.
• Experience managing and scaling IT operations, infrastructure, and support services in a medical device, life sciences, healthcare, regulated, or growth-stage organization highly preferred.

Skills & Abilities

• Demonstrated ability to establish responsible IT governance, policies, and tool-vetting processes.
• Strong troubleshooting and problem-solving skills with the ability to prioritize and resolve technology issues based on business impact.
• Proven ability to manage IT support, service levels, and technology budgets.
• Demonstrated ability to manage IT infrastructure, technology assets, access controls, vendors, and support services while maintaining reliable and secure IT operations.
• Proven ability to implement and maintain cybersecurity controls, security awareness, and incident response practices.
• Proven success in supervising, coaching, and developing technical staff, including setting priorities, holding accountability for service quality, and managing performance.

Physical Requirements

• Ability to perform routine physical tasks, including lifting to 20 pounds.
• Comfortable working in a sitting position and performing repetitive tasks.

Work Location and Travel

This position will report to our Company Headquarters in Valencia, CA. with minimal travel opportunities based on interest and business need.

Company Description

SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases.

Department: Operations

Reports To: VP Operations

FLSA Status: Exempt

Location: Valencia, CA

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Candidates must have and maintain authorization to work within the United States as a condition of employment.

We are proud to be an equal opportunity employer and we value diversity. SetPoint does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.