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.
Summary
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 NetSuite 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.
Why This Role
- 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.
What You Will Do
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 NetSuite 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.
What Success Looks Like
- 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.
Qualifications
Required- Bachelor's degree in Information Systems, Business, Accounting, Engineering, or a related field.
- 8+ years of business systems experience, including leading multiple system implementations, at least one of them an ERP.
- Experience across more than one type of business system, such as ERP, CRM, eQMS, PLM, or HRIS, and the integrations between them.
- Strong knowledge of finance, supply chain, and manufacturing processes, such as procure-to-pay, order-to-cash, and inventory.
- Experience managing implementation partners, vendors, and system budgets.
- Experience in a medical device, pharma, or biotech company.
- Able to work with executives and non-technical users and explain trade-offs in plain language.
- Comfortable in a lean, fast-paced startup.
Preferred- NetSuite experience, including OneWorld; NetSuite certifications a plus.
- Experience launching commercial systems for a medical device company, such as CRM, order management, or consigned inventory.
- Experience with Class III or other highly regulated products.
- Experience supporting international operations, especially in Europe.
- Experience building or leading a small systems team.
- SOX, audit-readiness, or computer system validation experience.
Environment
- Office: Irvine, CA, onsite Monday to Thursday.
- Travel: up to 15%, including Stuttgart, Germany and vendor sites.
Hours: some early-morning meetings with the German team.
CompensationThe anticipated base salary range for this position is $280,000 – $315,000 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 StatementKardion 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.
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