Teams at ICU Medical

Develop, maintain, and publish Supply Chain and Manufacturing BI reports and dashboards (OBIEE/Power BI/Excel). Gather requirements, ensure data integrity, migrate data to BI marts, perform user acceptance testing, automate recurring reports, provide training and troubleshooting, and support ad hoc analyses to improve operational efficiency and KPIs.

Provide computer system validation and assurance support for cGMP-regulated systems. Create, review, execute, and document validation deliverables (IQ/OQ/PQ), coordinate revalidation, assess periodic reviews, and liaise with QA, IT, Engineering and business stakeholders to ensure compliance with GAMP, cGMP, 21 CFR Part 11, EU Annex 11 and ISO standards.

Perform biocompatibility assessments and toxicological evaluations for medical devices per ISO 10993 and related standards. Review test data and protocols, develop biological evaluation plans and mitigation strategies, support regulatory submissions (FDA 510(k), EU MDR), collaborate with cross-functional teams and external labs, and contribute to DHF remediation and quality compliance.