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Principal Risk Management Specialist

LanceSoft INC
Mansfield, Massachusetts, United States
October 05, 2017


Lead risk management related activities for existing devices and support post-market quality by assisting with analysis and investigation of product or quality system issues and carrying out continuous improvement efforts

Risk assessment, maintenance, and management as documented within the risk management files, providing post market quality support and guidance through nonconformity assessment, supporting health hazard assessments and contributing to the various aspects of CAPA such as containment determination, root cause investigation, and corrective action planning by utilizing their subject matter expertise across the organization


BS Degree in Engineering or associated scientific discipline

4+ years medical device experience in Quality or Development Engineer position

Working knowledge of product risk management standards and tools (ISO14971, IEC 60601, pFMEA, etc.)

Working knowledge of Quality Engineering and medical device regulations (FDA 21CFR820, ISO13485)