Padmi

Senior Solutions Architect-Enterprise Solution Architecture (Kochi)

IndiaPosted 2 months ago
Electrical Electronics And Computer Hardware EngineeringSeniorFull Time; Regular
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Minimum Required Experience : 0 years Full Time Skills Device Testing EMI EMC Description 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 equipments. - Support in Certification (CTF) & accreditation (NABL) of the Labs. - 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. - Solid working knowledge of English language (oral and written) Minimum Required Experience : 0 years Full Time Skills Device Testing EMI EMC Description 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 equipments. - Support in Certification (CTF) & accreditation (NABL) of the Labs. - 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 r

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