Project Manager (Remote)
Role: Risk Management SME
Location: Remote
Duration: 12 Months
Summary/Description
Location: Remote
Duration: 12 Months
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 support of 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.
- To 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 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, 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.
- 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 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
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Project Management and Information Technology -
Industries
Staffing and Recruiting
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