Kardion

Heart pump medical device company

Global Information Technology Director

IT OperationsConfirmed live in the last 24 hours

Full-timeIrvine, CA, USA$200k - $245k /yr

About the Job

Requirements

At least 10 years of progressive information technology experience, including at least 4 years leading teams and owning an IT function or major domain.
Direct experience leading or heavily contributing to an enterprise resource planning implementation, migration, or major upgrade.
A proven track record building and scaling IT capability in a growing organization across 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 through a combination.
Experience supporting multi-site operations, including at least one international site, and ability to communicate complex technical and risk topics to executives, auditors, and non-technical business partners.
A bachelor's degree in information technology, computer science, or engineering, or equivalent practical experience.
The role is based in Irvine, California and is fully onsite.
Ability to support global colleagues and critical deployments outside standard business hours occasionally.

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 internal resources, trusted partners, or both.
Own incident response, third-party risk management, and 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.
Oversee the Irvine facility and physical security and access.
Travel periodically to Stuttgart, Germany.

Desired Qualifications

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

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.

What We're Looking For
Required

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 $200,00-230,000 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.

About the Company

Kardion

Heart pump medical device company

Kardion is a medical technology company developing a catheter-based heart-support system. The company researches, engineers, tests, and prepares clinical and manufacturing programs for an implantable cardiovascular device. It serves clinicians, patients, researchers, regulators, clinical partners, and medical-device suppliers. Its operating model centers on device development coordinated across engineering, clinical, quality, regulatory, and manufacturing teams. Teams work across biomedical engineering, clinical affairs, quality, regulatory, manufacturing, research, and operations. Its work connects cardiovascular medical devices expertise with coordinated delivery for clinical and healthcare stakeholders.

Company size: Not listed
Company stage: Not listed
Total funding: Not listed
Headquarters: Not listed
Founded: Not listed

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