Job Information
Insight Global LEAD QE Consultant in New York, New York
Job Description
Preparation of HW engineering technical documentation (Desing History File) for medical device including accessories for clinical trials and FDA 510K Submission
Establish Verification & Validation testing plan/protocol in cooperation with Engineers based on existing development data
Coordinate with Product development teams to create development documents that reflect Product Requirements
As a Project Manager, Cooperation with necessary personnel and departments and project management in creating DHF
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 .
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Skills and Requirements
Experience in taking the lead in writing technical documents, FDA 510K submission
Strong understanding of relevant regulatory requirements (21 CFR 820.30, ISO 13485 Design and Development, etc.)
Minimum 5+ years' experience in a regulated product development/systems environment
Working experience with the following standards: IEC 60601-1, IEC 61010-1, ISO 14971, ISO 13485
Bachelor's degree in Electronics, Mechanical engineering
Able to work during Korean working hours
Preferred Qualifications Experienced in RF and EMC testing and troubleshooting
Experience in optical devices development/RA
Able to communicate in Korean 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.