Description:
The EMI/EMC Engineer is responsible to support for client Healthcare products qualification & certification. The EMI/EMC Lab tests medical devices & systems per the requirements of IEC 60601-1-2, Medical Design Standards-3rd & 4th Edition, IEC particular and collateral Standards.
Duties include (but are not limited to):
- Support EMI/EMC tests of Imaging (CT, MRI, PET, X-Ray, Mammo, C-Arm, Bone Densitometer) & Clinical care (Anesthesia & Respiratory Care, Ventilators, Incubators, Baby Warmers, Fetal Monitoring Systems, Bedside Monitors, Central Stations, ECG Machines) products.
- Understand Product Test Plans & EMI/EMC Test Plans.
- Perform Test Setups as per the standard requirements.
- Acquiring Test Data from DAQ and related SW and record the test results.
- Prepare test observation sheets for the test results.
- Compile test results and complete Test Reports for submittal to Modality.
- Assure all equipment is operational and calibrations are current.
- Maintain operation of all automated equipment and test control software.
- Support calibration of Lab equipment’s.
- Support in 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 client 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.
- 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.
- Effectively support implementation & training of current regulatory requirements
Qualifications:
- Bachelors / Masters in Electrical / Electronic / Mechatronics Engineering
- Experience in Design & Development, Testing, Qualification, Certification of the Products with IEC or equivalent standards.
- 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 client healthcare products
- 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.
- Strong working knowledge of English language (oral and written)
