Manager, Global Business Systems

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 Manager, Global Business Systems owns the systems Kardion runs on, across the U.S. and Germany and across every part of the company: finance, supply chain and manufacturing, quality, product development, HR, and, as we approach launch, sales and customer operations. You will set the roadmap, choose and implement the right tools, connect them so data flows cleanly, and make sure they scale as we grow from a development-stage company to a commercial one.

Your first major project is our Net Suite ERP implementation. From there, you will build the commercial systems we need to sell, ship, and support our heart pump system in U.S. hospitals.

• Build the full systems foundation of a Class III medical device company, from development through commercial launch.
• Work across every function and both sites, with direct visibility to the executive team.
• Own the roadmap, budget, and vendor decisions.
• Grow the function and your own team as Kardion grows, with room to grow into a broader leadership role.

Strategy and roadmap

• Own the global business systems roadmap across ERP, quality management (eQMS), product lifecycle management (PLM), HR, commercial, and collaboration tools.
• Partner with leaders in Finance, Supply Chain, Operations, Quality, Regulatory, R&D, HR, and Commercial to understand how they work and what they need next.
• Lead system selection: requirements, vendor demos, cost, contracts, and business cases for leadership.
• Manage the business systems budget, licenses, and vendor relationships.
• Define how systems connect, with one source of truth for key data such as items, suppliers, customers, and employees.

Implementations

• Lead implementations from planning through go-live, starting with our Net Suite ERP implementation.
• Manage implementation partners to scope, schedule, and budget, and report progress to leadership.
• Translate business needs into system setup, workflows, and reports.
• Implement traceability, inventory, and supplier functions to the requirements and design set by Quality and Supply Chain.
• Plan and run data migration, testing, cutover, and post-go-live support.
• Set up systems for our U.S. and German entities, including multi-currency and intercompany needs.

Commercial readiness

• Build the systems we need to sell and support our product in U.S. hospitals, working with Sales, Marketing, Finance, Supply Chain, and Quality.
• Implement CRM for sales and marketing teams.
• Set up order-to-cash for hospital customers, including contracts, pricing, and invoicing.
• Set up tracking for field and consigned inventory at hospital sites.
• Implement customer service tools, with a clear handoff of product complaints to Quality.
• Time these systems to the launch plan so they are ready before we need them.

Global operations and data

• Support consistent processes and systems across Irvine and Stuttgart while meeting local requirements.
• Partner with IT and Legal on data privacy (including GDPR), security, and access for business systems.
• Maintain access controls, segregation of duties, and system documentation, and follow Kardion's QMS change control process for all system changes.
• Partner with Quality and Regulatory to define which systems and functions fall under quality system requirements, and support validation where they require it.

Run, improve, and build the team

• Own day-to-day support, enhancements, and releases for business applications.
• Build reports and dashboards for leaders across the company.
• Train users and build a network of super users at each site.
• Automate manual work and simplify processes as the company grows.
• Hire and develop a small business systems team as the company grows.

• First year: ERP implementation on schedule and on budget, with a smooth go-live. A global business systems roadmap agreed with leadership. Users in Irvine and Stuttgart trained and supported.
• By commercial launch: CRM, order-to-cash, and field inventory systems live and ready for our first hospital customers. Leaders across the company working from reliable data and reporting.

Required

• Bachelor's degree in Information Systems, Business,…