Teams at Danaher Corporation

Manage planning and execution of IVD/medical device clinical studies from concept to close-out, ensuring GCP and regulatory compliance, site selection and oversight, data integrity, QMS harmonization across OpCos, stakeholder communication, and achievement of study milestones.

Design, develop, and troubleshoot high-density multi-layer PCBs and microcontroller-based subsystems for medical diagnostics. Own hardware from concept to release, ensure compliance with IEC 60601/ISO 13485/FDA regulations, coordinate EMC/safety testing, perform root cause analysis, and collaborate with cross-functional teams to resolve manufacturing and field issues.

Design and redevelop mechanical hardware for diagnostic/biotechnology products. Own hardware development from concept to release, lead design change processes, perform design verification, root-cause analysis, and corrective actions. Collaborate cross-functionally to resolve manufacturing and field issues, conduct risk assessments and design reviews, and validate designs through analysis and testing.