Risk Management SME

Job Title: Risk Management SME
Location: On-site 2x a week at any of the following sites: Mansfield, MA / Princeton, NJ / Cincinnati, OH / Salt Lake City, UT / Irvine, CA
Duration: 11+ Months (Possible Extension)
 
Pay Rate: $84.39/hr. on W2

Summary/Description:
This role provides subject matter expertise in Risk Management within the Design Quality Assurance (DQA) team. The individual will perform gap assessments, plan, organize, execute, and report usability and risk management activities, collaborating across cross-functional teams. This position supports EU MDR remediation projects of varying product types and complexities, engaging with design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.
 
Essential Duties & Responsibilities:

• Conduct thorough gap assessments of existing usability and risk management documentation against EU MDR requirements and relevant standards, including ISO 14971:2019 and IEC 62366-1:2015.
• Provide risk management leadership and guidance throughout remediation projects.
• Develop and improve processes, procedures, practices, tools, and technology to support continuous improvement in risk management.
• Lead the development and implementation of key performance indicators (KPIs) and metrics for risk management processes.
• Support post-market surveillance activities, including creating Health Impact Assessments and Health Hazard Evaluations.

 
Qualifications / Experience Required:

• Education: Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical).
• Experience:
  • 5–7 years in the medical device industry with subject matter expertise in Risk Management (ISO 14971:2019) for all classes of devices.
  • Expertise in statistical techniques to calculate probabilities of hazardous situations.
  • Knowledge of industry best practices in Usability Engineering and Risk Management processes, tools, and technology.