Job Description Insight Global is seeking a Technical File Reviewer (Product Assessor) to join the business assurance group for one of our Inspection and Certification clients. This position will be responsible for conducting comprehensive assessments of soft tissue medical devices through reviewing technical files. During this process, this person will focus heavily on the electronics of each product and ensure that technical files adhere to requirements outlined in European Medical Device Directive and Medical Device Regulation for Class I/ IIa /IIb and/or Class III medical devices. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements Bachelors degree in Science or Engineering (preferably electrical engineering) 5+ years of experience in designing, manufacturing, or testing medical devices Knowledge of European medical device standards and regulations (93/42/EEC, 2017/745) Experience with medical devices incorporating software / utilizing software / controlled by software (MDS 1009) Excellent communication skills through electronic mediums Experience conducting product assessments for another certification organization Previous experience with soft tissue products null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.