Global IT Director

Kardion Inc.; Irvine (CA); On-site; USD 200,000 - 245,000; Full time

Job summary

Kardion is seeking a Director of Global Information Technology to define and execute the enterprise technology strategy across the United States and Germany, unifying the global IT organization and advising executive leadership.

You will build a multi-year roadmap, govern regulatory IT processes, oversee security, data, applications, and infrastructure, and lead a team across Irvine and Stuttgart to enable growth and risk-managed operations.

Qualifications

• 10+ years of progressive information technology experience, including 4+ years leading teams and owning an IT function or major domain.
• Direct experience leading or heavily contributing to an ERP implementation, migration, or major upgrade.
• Proven track record building and scaling IT capability in a growing organization, across both internal teams and external partners.
• Working knowledge of modern cloud, identity, and endpoint platforms sufficient to guide architecture decisions and evaluate vendor proposals.
• Accountability for an information security program, whether delivered internally, through partners, or a combination.
• Experience supporting multi-site operations, including at least one international site, with the ability to communicate complex technical and risk topics clearly to executives, auditors, and non-technical business partners.
• Bachelor's degree in information technology, computer science, engineering, or equivalent practical experience.

Responsibilities

• 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 for employee onboarding and offboarding, support responsiveness, and asset management.
• Oversight of the Irvine facility and physical security and access.

Job description

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.

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.

Position Summary

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.

What You'll Do

Strategy and Leadership

• 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.

Enterprise Applications and Data

• 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.

Regulated Systems and Audit Readiness

• 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.

Cybersecurity, Privacy, and Risk

• 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.

Infrastructure and Workplace Technology

• 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 for employee onboarding and offboarding, support responsiveness, and asset management.

Facilities

• Oversight of the Irvine facility and physical security and access.

Required

What We're Looking For

• 10 or more years of progressive information technology experience, including 4 or more years leading teams and owning an IT function or major domain.
• Direct experience leading or heavily contributing to an ERP implementation, migration, or major upgrade.
• Proven track record building and scaling IT capability in a growing organization, across both internal teams and external partners.
• Working knowledge of modern cloud, identity, and endpoint platforms sufficient to guide architecture decisions and evaluate vendor proposals.
• Accountability for an information security program, whether delivered internally, through partners, or a combination.
• Experience supporting multi-site operations, including at least one international site, with the ability to communicate complex technical and risk topics clearly to executives, auditors, and non-technical business partners.
• Bachelor's degree in information technology, computer science, engineering, or equivalent practical experience.

Preferred

• Medical device, pharmaceutical, biotech, or diagnostics experience strongly preferred.
• Depth in one or more specialist areas within the scope of this role, such as information security, infrastructure, enterprise applications, or validation.
• Relevant certifications such as CISSP, CISM, ITIL, or PMP.

Physical Demands and Work Environment

• Frequent use of a computer keyboard, monitor, and mouse; frequent sitting, standing, and walking; occasional lifting or moving of objects of various weights.
• Irvine, California based. This is a fully onsite position, with periodic international travel to Stuttgart, Germany.
• Fast-paced environment with shifting priorities and multiple concurrent projects, including occasional work outside standard business hours to support global colleagues and critical deployments.

Compensation

The anticipated base salary range for this position is $200,00-245,000 annually. Actual compensation will be determined based on experience, qualifications, skills, and location. Kardion offers a comprehensive benefits package including medical, dental, and vision coverage, 401(k), and paid time off.

Equal Opportunity Statement

Kardion is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.