Risk Management SME

Job Title: Risk Management SME
Location: Mansfield, MA 02048 (Hybrid - 2 Days onsite)
Duration: 11 Months

Job 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.

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.

Qualifications: 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). Must have experience in remediating risk management files for EU MDR. Statistical knowledge and familiarity with Minitab are a plus. Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools, and technology.