This candidate has to have infusion pump experience, either as a hardware or software Quality engineer or R&D hardware or software or system engineer
Provide Risk Management technical expertise through the product life cycle.
Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies.
Drive the concept of Systems Risk Analysis across the organization.
Work with R&D and Sustained Engineering on the development and incorporation of Risk Management during all design phases for new and/or product enhancements.
Facilitate development and completion of risk assessments.
Work with all production and post-production functions (manufacturing, post market surveillance, complaints, CAPA, Corrections and Removals, Change Control, Supplier Quality, acceptance activities) to ensure the proper application, use and updates of risk management files.
Work with Clinical personnel on creation of appropriate harm/hazard analysis for issues potentially impacting patient outcomes.
Keep up to date on new regulations and standards that affect Risk Management for medical devices. Ensure Risk Management procedures, processes and files are updated where required.
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams.
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