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GE Healthcare at http://www.gehealthcare.com provides transformational medical
technologies and services to meet the demand for increased access, enhanced quality and more affordable
healthcare around the world. GE works on things that matter - great people and technologies taking on tough
challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,
biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps
medical professionals deliver great healthcare to their patients.
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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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.
Duties include (but are not limited to):
1. Perform tests of customer products per submitted Safety Test Plans and associated standards:
2. Assists customers in identifying and solving Safety related issues
3. Write and Review Safety Product Test Plans.
4. Compile test results and complete Safety Test Reports for submission to Modality Safety Leader.
5. Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures.
6. Oversee Safety Laboratory test equipment:
i. Assure all equipment is operational and calibrations are current.
ii. Maintain operation of all automated equipment and test control software.
iii. Define new equipment needs per changes and additions to the Safety test standards.
7. Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.
8. 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.
9. Perform Safety testing of customer products per submitted Test Plans and applicable standards
Quality Specific Goals:
1. 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
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. 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
5. Complete all tests in compliance with procedures and regulations
6. Complete all planned Quality & Compliance training within the defined deadlines
7. Identify and report any quality or compliance concerns and take immediate corrective action as required
8. Effectively support implementation & training of current regulatory requirements
1. Bachelors degree in Engineering, Biomedical Engineering, Physics, Chemistry or closely related discipline; or equivalent (defined as a High School Diploma/GED and 4 years relative work experience)
2. 4 years' experience product design and development
3. Knowledge of Safety regulation: IEC 60601-1, Collateral and Particular
4. Awareness of Local and International Regulatory Agencies
5. Knowledge of a New Product Introduction process
6. Knowledge of Quality Management Systems including IEC/ISO 17025
7. Ability to manage multiple activities effectively.
8. Ability to communicate effectively with engineers from different disciplines and varying levels of experience.
9. Clear thinker, action oriented, high energy, self-starter.
10. Effective team player with motivating skills.
11. Strong working knowledge of English language (oral and written)
1. Previous experience in an ISO/IEC 17025 accredited lab
2. 5 years' experience in the regulated medical device industry
3. Knowledge of process improvement tools (six sigma, lean, ISO, TQM)
4. Strong organizational skills with high attention to detail
5. Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations
6. Excellent team-player skills w/global mindset
7. Excellent interpersonal, organizational, communication and influencing skills
8. Working knowledge of GEHC products
9. Strong people networking skills.
Locations: United States ; Wisconsin; Waukesha
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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