Perform safety certification evaluations for medical devices and measurement, control, and laboratory equipment under UL/IEC standards. Review medical device development documentation, including risk management, software, and usability materials; plan and conduct evaluations; issue test reports; communicate with customers; and provide technical support for new customer development.
JOB DESCRIPTION
의료기기 안전인증 엔지니어 업무
RESPONSIBILITIES
QUALIFICATIONS
ABOUT US
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.
ABOUT THE TEAM
Every product needs to be safe. But for medical devices, it's absolutely essential. For manufacturers, getting medical devices approved can be incredibly complex. That's where our team of experts comes in. Together, we help improve medical outcomes. We test, advise and use our world-class knowledge to help manufacturers navigate changing standards and regulations, so they can provide people around the world with innovative products that save and improve lives. Whether it's equipment to help someone walk again or an incubator for a premature baby, our experts are behind them all, helping to ensure their safety. Join our team, connect with global experts and help shape the next generation of medical technology.
의료기기 안전인증 엔지니어 업무
RESPONSIBILITIES
- 의료기기 안정성 평가 인증업무. (UL/IEC 60601-1)
- 계측, 제어, 실험실 기기의 안정성 평가 인증업무 (UL/IEC 61010-1)
- 의료기기 개발에 관련된 문서 검토 (위험관리 , 소프트웨어, 사용성 문서 등. )
- 안정성 평가를 위한 계획 수립 및 평가.
- 시험성적서 발행 및 고객과 의사소통.
- 신규 고객 개발을 위한 기술지원
QUALIFICATIONS
- 학력: 4년제 이상 / University Degree or above,
- 전공: 공학 전공자(의공학, 전기, 전자 또는 관련학과 우대) / Engineering (Biomedical, Electrical or Electronic Engineering).
- 신입 또는 경력 (정보통신기기, 가전기기, 각종 전기/전자기기 및 의료기기 안전성 평가경력 우대 - 의료기기RA 경력만 있는 경우 제외)
- 경력기간: 10년 미만
- 항목별 '필수'와 '우대' 요건 반드시 구분
- 전기• 전자기기/의료기기(우대) / 측정,제어 및 실험실용 전기기기 안전인증 관련경력
- 국내/국제 의료기기 인• 허가 경력(우대)
- 의료기기 관련 위험관리, 소프트웨어, 사용성평가 경험(우대)
- 의료기기 개발 경력(우대)
- 비지니스 영어회화 가능자 (우대)
- 전기/전자 국가공인자격증(우대)
ABOUT US
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.
ABOUT THE TEAM
Every product needs to be safe. But for medical devices, it's absolutely essential. For manufacturers, getting medical devices approved can be incredibly complex. That's where our team of experts comes in. Together, we help improve medical outcomes. We test, advise and use our world-class knowledge to help manufacturers navigate changing standards and regulations, so they can provide people around the world with innovative products that save and improve lives. Whether it's equipment to help someone walk again or an incubator for a premature baby, our experts are behind them all, helping to ensure their safety. Join our team, connect with global experts and help shape the next generation of medical technology.
UL Solutions San Francisco, California, USA Office
San Francisco, CA, United States
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