About Us: GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: The Safety Engineer is responsible for the technical operations of the Safety Lab, which supports Safety compliance testing of customer products. The Safety Lab primarily tests medical devices and systems per the requirements of IEC 60601-1, Medical Design Standards-3rd Edition, IEC particular and collateral Standards.
Essential Responsibilities: Perform tests of customer products per submitted Safety Test Plans and associated standards: Assists customers in identifying and solving Safety related issues Write and Review Safety Product Test Plans. Compile test results and complete Safety Test Reports for submittal to Modality Safety Leader. Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures. Oversee Safety Laboratory test equipment: o Assure all equipment is operational and calibrations are current. o Maintain operation of all automated equipment and test control software. o Define new equipment needs per changes and additions to the Safety test standards. Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible. Mentor and Assist with training of Modality Safety Engineers and Technicians to assure competency level of individuals performing Safety tests are appropriate per the relevant standards and procedures. Perform Safety testing of customer products per submitted Test Plans and applicable standards
Qualifications/Requirements: BS Electrical engineering, Biomedical Engineering, Physics, Chemistry or closely related discipline & and 4 years of product design and development experience Knowledge of Safety regulation: IEC 60601-1, Collateral and Particular Awareness of Local and International Regulatory Agencies Knowledge of a New Product Introduction process Knowledge of Quality Management Systems including IEC/ISO 17025 Ability to manage multiple activities effectively. Ability to communicate effectively with engineers from different disciplines and varying levels of experience. Clear thinker, action oriented, high energy, self-starter. Effective team player with motivating skills. Strong working knowledge of English language (oral and written)
Desired Characteristics: . Previous experience in an ISO/IEC 17025 accredited lab 5 years’ experience in the regulated medical device industry Knowledge of process improvement tools (six sigma, lean, ISO, TQM) Strong organizational skills with high attention to detail Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations Excellent team-player skills w/global mindset Excellent interpersonal, organizational, communication and influencing skills Working knowledge of GEHC products Strong people networking skills.
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