Global IT Director

About Kardion

Kardion is a cardiovascular medical device company developing next-generation mechanical circulatory support technology, with dual headquarters in Irvine, California and Stuttgart, Germany. Every moment matters. Our team is building toward a future where circulatory support gives patients and clinicians more time, more options, and more certainty.

The Director, Global Information Technology defines and executes Kardion's enterprise technology strategy across our United States and German operations. This leader will unify and lead the global IT organization, serve as the primary technology advisor to executive leadership, and ensure technology investments are directed toward the areas of greatest value to the business.

The role requires both strategic influence and technical depth. The Director will define a multi-year information technology roadmap, report on performance, risk, and investment to executive leadership, and remain close enough to the technology to guide architecture decisions and lead the team through execution. Building on a foundation established by our teams in Irvine and Stuttgart and our external partners, the Director will bring both sites together under a common global operating model and continue to mature the capabilities expected of a regulated, multinational medical device company.

• Define and own Kardion's global IT strategy, roadmap, and budget, and serve as the primary technology advisor to the CEO and executive leadership team.
• Establish a single global operating model across Irvine and Stuttgart, including standards, service levels, and a sustainable balance of internal capability and specialized external expertise.
• Build, lead, and develop the global IT organization, and report on performance, risk, and investment to executive leadership.

• Own the enterprise application portfolio and integration architecture, partnering with functional leaders to translate business requirements into system capability and maintain a coherent landscape as the company grows.
• Provide leadership and direction to the ERP function, ensuring the program supports manufacturing, quality, supply chain, and finance at commercial scale.
• Strengthen data management, reporting, and analytics so leadership has reliable visibility across the business.
• Develop and own an AI governance framework covering approved tools, data protection, intellectual property, and responsible use.

• Own computer system validation for regulated systems in partnership with Quality Assurance.
• Ensure IT processes, controls, and documentation satisfy FDA and ISO 13485 requirements, including electronic records, access control, change control, and records retention.
• Serve as the IT subject matter expert during regulatory inspections, notified body audits, and internal audits.

• Own the enterprise information security program, aligned to a recognized framework and delivered through a combination of internal resources and trusted partners.
• Own incident response, third-party risk management, and the IT controls that protect the integrity of business and financial systems.
• Ensure compliance with global data privacy requirements, including GDPR and applicable US state law, in partnership with Legal and HR.

• Own global infrastructure architecture including cloud, identity, network, endpoint, and collaboration platforms across both sites.
• Ensure reliable, secure, and audit-ready technology support for laboratory, engineering, and manufacturing environments.
• Establish business continuity and disaster recovery capability, and set standards…