Integrated Resources
Risk Management - SME
Integrated Resources, Irvine, California, United States, 92713
Job Title: Risk Management SMEWork Site/Location: This will be remote.Must Have Skill :- RM SME position, experience with ISO14971:2019 is necessary. Risk management experience should not be before 2020. They also need to know how to apply statistics beyond process capability and SPC charts.Risk Management SMEMust have working knowledge of ISO14971:2019, MDR requirements, and IEC62366-1:2015.Must have experience in remediating risk management files for EU MDR.Statistical knowledge and familiarity with Minitab are a plus.Must have strong communication skills.Must be able to work normal business hours.Other criteria are provided in the JD.
Summary/DescriptionThis is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams. This role is responsible for support of EU MDR remediation projects of varying Product and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.
Essential Duties and ResponsibilitiesTo perform this job successfully, the individual must be able to perform each essential duty satisfactorily:• Perform thorough gap assessment of existing usability and risk management documentation aProductst EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015• Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project.• Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.• Leads development and implementation of key performance indicators and metrics for the risk management process.• Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations.Qualifications/Experience RequiredThe requirements listed below are representative of the knowledge, skill, and/or ability required for this position.• Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)• 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices• Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1).• Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology.
Summary/DescriptionThis is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams. This role is responsible for support of EU MDR remediation projects of varying Product and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.
Essential Duties and ResponsibilitiesTo perform this job successfully, the individual must be able to perform each essential duty satisfactorily:• Perform thorough gap assessment of existing usability and risk management documentation aProductst EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015• Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project.• Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.• Leads development and implementation of key performance indicators and metrics for the risk management process.• Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations.Qualifications/Experience RequiredThe requirements listed below are representative of the knowledge, skill, and/or ability required for this position.• Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)• 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices• Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1).• Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology.