Risk Management SME

Description:

• Do not need a director or VP-level. Needs an engineer, someone who has Bach of Science in Mechanical Engineering, systems, or electrical.
• A worker at an engineering level who will create content, developing design control.
• Need to have expertise in Risk and Risk Management
• Know ISO 14971
• Working knowledge of the usability standards.

Primary Responsibility:

• Protocol development
• Understanding of statistical methods and techniques
• Remediation of Risk management files and potentially creation of usability engineer files.
• Roll up their sleeves and work. Wants someone to fix the problem and not consult on what is wrong.

Summary/Description
This 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 supporting EU MDR remediation projects of varying scope and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.

Essential Duties and Responsibilities
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:

• Perform a thorough gap assessment of existing usability and risk management documentation against 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, practices, 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 Required
The 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 working within the 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.