GE HealthCare EMC Safety & Regulatory Engineer 

South Korea 

757618298

The EMC, Safety & Regulatory Engineer delivers input on initial hardware design decisions and subsequent design stages, and keeps up to date on global medical regulation trends. Particular understanding of following are advantageous:General safety requirement (IEC60601-1) to particular (IEC60601-2-xx) and of IEC 60601-1-2 (EMC) for diagnostic ultrasound systems, and safety & EMC debugging of design products.

[HR Talk]

글로벌 의료기기 회사 GE Ultrasound 성남 R&D Center에서EMC, Safety & Regulatory Engineer를 채용합니다. 하드웨어 설계에 있어 전자파 안전 책임, IEC6061을 비롯한 의료전자장비 표준 및 안전 규정에 관리 업무를 주로 다루며, 5년 이상의 유관 업무 경력자를 우대합니다.

Key responsibilities include:

• Involves design input on initial design steps.

• Make a set SAFETY / EMC Test Plans.

• Compile test results and complete SAFETY / EMC Test Reports for release.

• Review electrical design based on SAFETY / EMC compliance.

• Co- work and communication with other branch of GEHC.

• Assists design engineers for identifying source of SAFETY / EMC related issues.

• Verify proper equipment is used and calibrations are up to date.

• Well time and cost management.

• Well relationship with 3rd party test house and certificate company & f/u global RA.

• Verify product testing power requirements and facility needs.

Quality Specific Goals:

• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

• Complete all planned Quality & Compliance training within the defined deadlines.

• Identify and report any quality or compliance concerns and take immediate corrective action as required.

• Keep up-to-date on knowledge and understanding of current regulatory requirements for test laboratory within area of responsibility to ensure laboratory accreditations are maintained

• Complete all tests in compliance with procedures and regulations.

Required Qualifications:

• Associate degree in Electronics or related field with minimum 5 years experience as safety compliance engineer.

• Experience handling (IEC60601-1 : General safety requirement ), (IEC60601-2-xx: particular) ,collateral standard (IEC60601-1-2: EMC) and other relevant standards for medical devices.

• Strong analytical and problem-solving skills

• English skill – business level (writing & speaking)

• Ability to interpret technical writing documents (i.e. Engineering and Manufacturing)

• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

• Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations

Preferred Qualifications:

• Working knowledge of IEC 60601-1/ -1-2/ -2-37/ -1-6, IEC62366, IEC62304 and medical related standards.

• Previous experience in an ISO/ an ISO/IEC 17025 accredited lab.

• Experience working as electrical engineer in the medical or IT device industry.

• Demonstrated teamwork skills.

• Strong organizational skills with high attention to detail

• Ability to work effectively on cross-functional teams.

• Highly motivated self-starter, able to work on own initiative and well in a team environment.

• Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.