Jobs at ICU Medical

Provide quality assurance and regulatory compliance support for medical device hardware development and manufacturing. Lead design control activities, risk management, validation, design verification, investigations, CAPA, and audit readiness. Support cross-functional teams on product changes, monitor product quality data and trends, and ensure alignment with ICU Medical quality system and applicable standards/regulations.

The IT Applications Lead manages the production support and implementation of Manufacturing and Quality applications in Oracle E-Business Suite, overseeing incident management, supporting users, and leading enhancements and projects.

Manage the Regulatory Operations team to prepare, publish, and submit regulatory documentation and product/facility registrations for US, EU, and Canada. Develop global regulatory strategies, liaise with agencies, support inspections and audits, maintain regulatory data systems, and lead continuous improvement while managing and mentoring staff.

Lead and grow strategic non-acute accounts by driving sales growth, enterprise contracting, pricing strategy, cross-functional alignment, executive-level relationship management, and project execution to meet revenue targets.

The OIC Application Developer is responsible for designing, developing, and supporting enterprise integrations, focusing on Oracle EBS and SaaS applications using OIC, ensuring system stability and reliability.

The Oracle Applications Programmer develops, maintains, and customizes Oracle Applications, ensuring technical solutions align with business needs while supporting the production environment.

The Pharmacy Sales Specialist builds relationships to increase profitability, meets sales quotas, and provides support for ICU Medical products in oncology.

The Business Systems Analyst documents requirements and assists in the development and implementation of business systems projects, primarily using Oracle applications to enhance and support operations.

The Applications Programmer will develop and maintain Oracle Applications and EDI integrations, analyze requirements, work with Business Analysts, and provide technical support and solutions.

The Oracle Applications Integration Developer designs and supports integrations between Oracle EBS and various applications, performing troubleshooting, customizations, and ensuring system stability in a regulated environment.

The Senior Engineer manages product life cycles post-launch, analyzing changes, ensuring regulatory compliance, providing technical support, and mentoring junior engineers.

The Business Systems Analyst is responsible for gathering requirements, developing designs, and supporting implementation projects for various financial systems while liaising with multiple departments and improving processes.

The Wireless Networking Engineer will support wireless medical devices, troubleshoot enterprise networks, configure Cisco equipment, and manage server systems for R&D teams globally.

The Analyst, Business Systems is responsible for documenting requirements, implementing projects, guiding technical teams, and improving manufacturing processes using Oracle applications.

The Portfolio Sales Specialist manages key accounts to achieve sales targets for ICU Medical products, providing product knowledge and support, and developing business relationships.

The Engineer III, Automation provides technical leadership for automation improvements, evaluates existing processes, supports production, and oversees technical projects.

The Procurement Business Analyst collaborates with stakeholders to ensure effective use of procurement systems, manage enhancements, and support business requirements through data analysis and system documentation.

The Manager, Engineering - Quality ensures compliance with quality systems for electromechanical product development, leading Quality Engineers and supporting product lifecycle management and risk analysis.

Supports global and US medical device registrations by creating and maintaining registration dossiers, advising product teams, preparing agency meeting materials, evaluating regulatory impact of changes, and ensuring regulatory compliance of submissions. Serves as a regulatory liaison, contributes to strategy, and tracks deliverables to meet deadlines.

Investigate medical device customer complaints, perform root-cause analysis, write investigation reports, support CAPA and cross-functional communication, conduct testing of returned devices, analyze trend data, and provide quality engineering guidance to manufacturing sites and customers.