Cardiovascular medical device developer scaling manufacturing and quality systems
Kardion is a medical device company building cardiovascular technologies, founded in 2018 and now scaling from prototype to production. The tech stack reflects a hardware-first, compliance-heavy organization: CAD (SolidWorks), enterprise resource planning (NetSuite, SAP, Oracle), product lifecycle management (Polarion ALM, IBM DOORS), and manufacturing planning tools. Active hiring across engineering, operations, and finance—with senior and director-level roles dominating—signals transition from founding phase toward mature manufacturing operations, supported by concurrent projects in supplier governance, quality system buildout, and technology transfer.
Kardion develops cardiovascular medical devices targeting the clinical and interventional cardiology markets. The company is privately held, headquartered in Pleasanton, CA, with 51–200 employees and ongoing expansion into Germany. Current operational focus spans product development, manufacturing scale-up, and regulatory quality infrastructure. Active initiatives include supplier qualification and governance frameworks, end-to-end onboarding workflows, quality management system maturation, and ERP automation—all consistent with a company transitioning from R&D into regulated manufacturing. Recent pain points include contract negotiation complexity, global accounting scale challenges, and compliance/audit readiness, reflecting the operational overhead of bringing a medical device to market.
SolidWorks (CAD), NetSuite and SAP (ERP), Polarion ALM and IBM DOORS (product lifecycle), Microsoft Project (planning), Sophos and FortiGate (security), plus Windows, iOS, and Android across endpoints.
Headquartered in Pleasanton, CA. Currently hiring in the United States and Germany, with a new headquarters build underway in Irvine.
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