Job Requirements

The Testing Engineer is responsible for testing GE Healthcare products. The Safety Lab primarily tests medical devices and systems per the requirements of IEC 60601-1, Safety Standards, IEC particular and collateral Standards. The EMI/EMC Lab tests medical devices & systems per the requirements of IEC 60601-1-2, essential performance for medical equipment with regard to Electromagnetic.

 

Duties include (but are not limited to):

Perform tests for Imaging (CT, MRI, PET, X-Ray, Mammo, C-Arm, Bone Densitometer) & Patient care solutions products (Anesthesia & Respiratory Care, Ventilators, Incubators, Baby Warmers, Fetal Monitoring Systems, Bedside Monitors, Central Stations, ECG Machines).Execute EMC, Safety & Environmental test plans for medical devices, ensuring they meet the requirements of standard IEC 60601-1, IEC 60601-1-2 and related EMC standards, Environmental Standards.Hands on experience for Conducting various EMC tests, including conducted emission (CE), radiated emission (RE), conducted susceptibility (CS), and radiated susceptibility (RS) tests, as well as ESD immunity testing.Hands on experience for Conducting various Safety, Thermal & Vibration testing per submitted Test Plans and applicable standards.Analyze test data, identify potential issues, and work with engineering teams to implement design changes and resolve compliance problems.Support team for external agencies Certification (CTF) / accreditation (NABL) of the Lab’s.Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.

Work Experience

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/positionComplete all planned Quality & Compliance training within the defined deadlinesIdentify and report any quality or compliance concerns and take immediate corrective action as requiredKeep 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 regulationsComplete all planned Quality & Compliance training within the defined deadlinesIdentify and report any quality or compliance concerns and take immediate corrective action as requiredEffectively support implementation & training of current regulatory requirements 

 

Qualifications:

Bachelors in Electrical / Electronics1 5 years of relevant industrial experience in the regulated medical device industry or similar industry.Experience in Design & Development, Testing, Qualification, Certification of the Products with IEC or equivalent standards.Working knowledge of Safety & EMI/EMC regulations: IEC 60601-1, IEC 60601-1-2 Collateral and Particular.Knowledge of Quality Management Systems including IEC/ISO 17025, Lab Accreditation & Certification.Excellent team-player skills w/global mindset Excellent interpersonal, organizational, communication and influencing skills  Working knowledge of GEHC products Ability to manage multiple activities effectively. Ability to communicate effectively with engineers from different disciplines and varying levels of experience.Strong people networking skills.Clear thinker, action oriented, high energy, self-starter.Effective team player with motivating skills.Strong working knowledge of English language (oral and written)

 

Preferred Qualifications:

Previous experience in an ISO/IEC 17025 accredited labKnowledge of process improvement tools (six sigma, lean, ISO, TQM)Strong organizational skills with high attention to detailAdaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations