Jobs at ICU Medical

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.

Lead design quality activities for medical devices: apply quality tools, ensure FDA and international regulatory compliance, manage design controls, risk management, V&V, CAPA, investigations, audits, and cross-functional product change coordination. Monitor product data for trends, support 510(k) and technical files, and drive closure of quality issues.

Perform final quality reviews of production and sterilization records, manage nonconforming product holds, release conforming finished goods through Oracle, maintain DHR and outsourced sterilization documentation, generate sterility and Certificate of Conformance letters, and ensure compliance with ISO 13485 and FDA requirements.

Provide clinical training, workflow assessment, and consultative support for ICU Medical infusion devices and software; lead go-live, post-go-live support, EHR integrations, and clinician education across cross-functional teams.

Supervise and coach service technicians to ensure safe, compliant, and timely repair and delivery of electromechanical medical devices. Manage compliance with QMS/global regulations, support audits, analyze repair data, drive continuous improvement with Lean 6S, and liaise with R&D and manufacturing engineering.

The Respiratory Sales Specialist manages ICU Medical's Respiratory Care sales, builds client relationships, and supports post-sales implementation while meeting revenue goals in the assigned territory.

Design, develop, implement, and support mission-critical web applications for manufacturing plants. Build and maintain Oracle database objects, integrate systems, create unit/integration tests, follow Agile practices, participate in on-call rotation, and collaborate with business users for requirements, documentation, and deployment.

Build and maintain relationships with hospital and alternate-site stakeholders to drive sales of ICU Medical infusion, devices, oncology, specialty products, and services. Manage CRM pipeline, meet territory quota, perform product demos and education, support field sales on contracts/pricing/backorders, attend team meetings, and travel frequently for implementations and go-lives.

The Lead will supervise a team, manage customer complaints, ensure compliance with medical device regulations, and provide training and guidance to staff.

Entry-level field-based sales role that builds hospital relationships, meets territory quotas, conducts product demos, manages CRM pipeline, supports field sales, and travels frequently to assist with implementations and education.

Entry-level field sales role building hospital relationships and expanding ICU Medical product usage. Manage CRM pipeline, meet territory sales quota, perform product demos, educate clinicians on clinical guidelines, support field sales on contracts and logistics, and travel frequently to assist with implementations and trainings.

Coordinate Oracle transactions and in-process data entry for product release from sterilization to distribution. Process component lot number and scrap entries, perform label printing, follow regulatory and company procedures, and support Keene production line closeouts. Maintain accuracy, prioritization, and independent work in a fast-paced environment.

Lead complex manufacturing quality investigations (NCMR, CAPA, complaints), drive defect-reduction and continuous-improvement projects, support validation/process changes, mentor junior quality engineers, and maintain process-control health and audit readiness.

Lead and develop a regional sales team to grow ICU Medical's Respiratory business in acute care hospitals. Drive sales strategy, manage pipeline and contracts, meet revenue and margin targets, cultivate key accounts, coordinate marketing and VOC reporting, and ensure team development and operational consistency.

Design, source, and improve injection molds and tooling for new and existing medical products. Lead tooling design reviews, generate tooling FMEAs, support CAPA tasks, use DFM, SPC, DOE and Six Sigma to meet yield, cycle-time, quality, and cost targets, and manage projects to completion.

Field-based clinical sales role selling capital infusion devices and software. Performs IV therapy assessments, develops clinical value propositions, advises stakeholders from clinical users to C-suite, acts as infusion SME, collaborates with sales and product teams, provides workflow redesign and product feedback, and supports adoption and training. Requires heavy travel.

Lead cross-functional sustaining engineering projects for on-market medical devices, managing change control, supplier assessments, validation/verification, risk-based solutions, and regulatory compliance to ensure product quality and continuity of supply.

Support medical device consumable development by applying QMS and risk-management tools, performing design reviews, CAPA investigations, DHF maintenance, audit support, and cross-functional quality activities to ensure regulatory compliance and product quality.

The role involves validating Oracle EBS systems, testing various modules, developing and coordinating tests, and collaborating with cross-functional teams to ensure quality and successful project execution.

The Device Sales Specialist builds relationships with key decision makers, meets sales quotas, conducts presentations, maintains expertise in ICU products, negotiates contracts, and develops customer relationships to drive sales success.