Risk Management SME - Medical Device Manufacturing

SRG is looking for a Medical Device Risk Management SME to join our team in Mansfield, Mass!

Duration: 12 months long term W2 contract

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.

Qualifications/Experience Required:

• 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

Essential Duties and Responsibilities:

• 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
  

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.