Testing Engineer

Testing Engineer

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.

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
• Effectively support implementation & training of current regulatory requirements

Qualifications:

• Bachelors in Electrical / Electronics
• 1-5 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 lab
• 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