Global IT Director: Medical Devices & Compliance

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

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.