Offer summary

Qualifications:

Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical), 5-7 years of experience in medical device industry with Risk Management expertise (ISO 14971:2019), Knowledge of statistical techniques for hazardous situations probabilities.

Key responsabilities:

Perform gap assessment on usability and risk documentation against relevant standards

Provide leadership, guidance, and supervision for risk management processes

Develop efficient processes/tools to enhance risk management

Support post-market surveillance by creating Health Impact Assessments

Collaborate with internal teams for EU MDR remediation projects

Job description

Job Title: Risk Management SMELocation: RemoteDuration: 12 MonthsDay to day: - Risk Management SME position, experience with ISO14971:2019 is necessary. Risk management experience should not be before 2020. They also need to know how to apply statistics beyond process capability and SPC charts.**

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.**

Essential Duties and Responsibilities**

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.

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 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.

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, 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.

Please contact HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

Required profile