Design Assurance Engineer
- 227
- 0
- 0
- 모집기간 : 채용시까지
◈ 직무 개요
- Develops and implements quality system documentation.
- Partner with cross-functional teams during product development to ensure design controls are implemented and maintained per applicable standards (e.g., ISO 13485, 21 CFR Part 820, ISO 14971).
- Support risk management activities in accordance with ISO 14971 (Risk Analysis, Hazard Analysis, FTA, FMEA, Mitigations).
- Develops and executes Design Verification and Design Validation protocols and reports to verify the device meets system, software, hardware, and mechanical requirements.
- Develop design control documentation and manage the Design History File (DHF) and Device Master Record (DMR) (e.g. Design & Development Plan, Design Inputs, Product Requirements, Trace Matrix).
- Perform design reviews and traceability analysis to ensure all requirements are verified.
- Ensure compliance with relevant test standards and guidelines including ISO, FDA, USP, and ASTM.
- Stay updated with the latest in robotic technology, medical device regulations, and safety standards
- Effectively collaborate with cross-functional teams, relevant subcontractors, and testing laboratories.
- Support Quality System processes where applicable (e.g. Supplier Management, CAPA investigations, Internal/External Audits)
- Partner with cross-functional teams during product development to ensure design controls are implemented and maintained per applicable standards (e.g., ISO 13485, 21 CFR Part 820, ISO 14971).
- Support risk management activities in accordance with ISO 14971 (Risk Analysis, Hazard Analysis, FTA, FMEA, Mitigations).
- Develops and executes Design Verification and Design Validation protocols and reports to verify the device meets system, software, hardware, and mechanical requirements.
- Develop design control documentation and manage the Design History File (DHF) and Device Master Record (DMR) (e.g. Design & Development Plan, Design Inputs, Product Requirements, Trace Matrix).
- Perform design reviews and traceability analysis to ensure all requirements are verified.
- Ensure compliance with relevant test standards and guidelines including ISO, FDA, USP, and ASTM.
- Stay updated with the latest in robotic technology, medical device regulations, and safety standards
- Effectively collaborate with cross-functional teams, relevant subcontractors, and testing laboratories.
- Support Quality System processes where applicable (e.g. Supplier Management, CAPA investigations, Internal/External Audits)
◈ 경력 요건
- Bachelor’s degree in engineering, preferably in Biomedical, Mechanical, Electrical, or related field. Material Science degree is also acceptable. Master’s degree is a plus.
- 2+ years of experience in quality engineering. Medical device experience is preferred.
- Working knowledge of ISO 13485, 21 CFR Part 820, and ISO 14971.
- Proficiency in reading and writing in English.
- Ability to work collaboratively in a fast-paced, dynamic environment.
- 2+ years of experience in quality engineering. Medical device experience is preferred.
- Working knowledge of ISO 13485, 21 CFR Part 820, and ISO 14971.
- Proficiency in reading and writing in English.
- Ability to work collaboratively in a fast-paced, dynamic environment.
◈ 우대 사항
- Startup experience.
- Working knowledge of ISO 10993 and ISO 11135 for sterile, disposable medical devices.
- Experience with IEC 60601 and IEC 80601 requirements and testing certification for electrical medical devices, robotic systems.
- Experience with product lifecycle management (PLM) software.
- Familiarity with medical devices cleanroom requirements.
- Experience with statistical analysis and software tools for data analysis.
- Fluent in English and Korean.
- Knowledge of FDA regulations and guidances .
- Experience with IEC 60601 and IEC 80601 requirements and testing certification for electrical medical devices, robotic systems.
- Experience with product lifecycle management (PLM) software.
- Familiarity with medical devices cleanroom requirements.
- Experience with statistical analysis and software tools for data analysis.
- Fluent in English and Korean.
- Knowledge of FDA regulations and guidances .
◈ 제출 서류 및 기타
- 국/영문 이력서 및 자기소개서
◈ 담당 컨설턴트
- 이건교 / 02-2016-6602 / [email protected]
`25.07.24(updated. `25.07.25)