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
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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
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.