Lead investigations into fielded product issues including performing the risk analysis for the issue with a comparison to the risk management files and impacts to existing risk mitigations.
Determine and initiate change request if risk management files need to be reviewed and updated.
Collaborate with Medical Safety to review and analyze field data, discuss the harm severity sources, and estimate the probability or harm occurrence.
Participate in the identification, assessment, and disposition of software anomalies.
Evaluate reliability impact of proposed design and manufacturing changes on existing market released product. This includes physical hardware changes as well as, embedded firmware, and health software applications.
Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with a product nonconformance, complaint, design, or manufacturing change.
Represent the organization as a technical contact for risk and reliability for processes such as: Non conformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations, Change Control and CAPA among others.