Jobs at Nihon Kohden America

Own and maintain the medical device Quality Management System (QMS): manage internal/external audits, CAPA, change/document/records control, metrics and management review. Lead quality systems personnel, provide training and cross-functional support, ensure regulatory compliance (FDA, ISO, Canadian MDR), and drive continuous improvement and inspection readiness.

Lead Quality Assurance and Regulatory Affairs as an executive, maintaining QMS compliance (FDA, ISO, Health Canada), oversee CAPA, complaints, audits, 510(k) and licensing submissions, support product lifecycle and cross‑functional commercial teams, and manage global quality/regulatory partnerships.

Conduct and document medical device product complaint investigations per FDA and ISO requirements. Interface with customers and cross-functional teams to determine root cause, drive corrective/preventive actions, maintain complaint files, perform trend analysis, and support audits and regulatory correspondence.

Provide tier‑1 phone and email support for Windows-based neurology medical devices and applications. Troubleshoot hardware, software, configuration and interoperability issues, assist with system configuration and updates, manage tickets, follow up on repairs/POs/QA requests, and escalate to higher support levels as needed. Participate in a rotating on-call schedule and document resolutions.

Lead development and execution of enterprise AI strategy, governance, architecture, and adoption. Coordinate cross-functional teams to identify use cases, enable responsible AI, support implementations, measure business value, and drive enterprise-wide AI literacy and standards.

Lead and manage the Quoting department and Quotation Coordinators to ensure accurate, timely quotes. Develop workflows, SOPs, and pricing/discount governance; collaborate with Product, Marketing, QC, RA, IT Commerce, and Sales Education to launch products, implement system improvements, and support high-value quoting. Monitor performance, remove bottlenecks, train staff, and maintain customer/vendor relationships while ensuring compliance and operational excellence.

Provide employee services and HRBP support, manage onboarding and events, develop training materials and visual communications, maintain HR data in ADP, perform data analysis and reporting, ensure compliance with employment laws, and drive process improvements to enhance employee experience.

The Sr. Manager of FP&A partners with leadership on financial management, oversees budgeting and forecasting, and enhances operational efficiency through data analysis and insights.

Provide level-1 technical support for Windows-based medical devices and applications: troubleshoot hardware/software/configuration issues, assist with system configuration and updates, handle customer inquiries about repairs/parts/orders, document resolutions, escalate complex issues to higher-tier support, and follow up on QA and repair-related items.

Provide level-1 technical support for Windows-based medical devices and applications: troubleshoot hardware/software/configuration issues, handle repair/status/part requests, document resolutions, escalate to higher-level support as needed, and follow up on QA, repair costs, and PO requests while adhering to company policies.

Provide clinical customer support and lead implementations of Nihon Kohden patient monitoring systems, develop and deliver training/support plans, troubleshoot clinical/monitoring issues, maintain nursing licensure, and travel frequently to customer sites to ensure successful deployments and ongoing support.

Provide clinical customer support and lead implementations of Nihon Kohden patient monitoring systems at customer sites. Develop and deliver customized training, lead implementation teams, offer ongoing in-person and phone support, maintain clinical competency and active nursing license, and travel extensively to complete projects to customer satisfaction.

Designs, implements, validates, and supports wired and wireless networks for patient monitoring systems. Performs site surveys, creates designs and documentation, stages and configures equipment, coordinates installations and cutovers, provides remote and on-site support, mentors junior engineers, and ensures adherence to standards and project timelines.

Manage and supervise clinical application staff delivering monitoring system training and support. Oversee hiring, onboarding, scheduling, performance evaluations, expense approvals, and customer training requests. Maintain clinical competency and nursing licensure, perform specialist duties as needed, and ensure team meets quality, client satisfaction, and departmental goals.

Provide clinical customer support and lead implementations of Nihon Kohden patient monitoring systems at hospital sites. Develop and deliver customized training/support plans, lead implementation teams, provide ongoing in-person and phone support, maintain clinical competency and active nursing licensure, and complete required documentation and travel (~80%).

Provide clinical customer support and lead implementations of Nihon Kohden patient monitoring systems. Develop and deliver customized training, lead implementation teams, provide ongoing onsite and phone support, maintain clinical competency and active nursing licensure, complete documentation and expense reports, and travel extensively to customer sites (approximately 80%).