Software Engineer-GCP Data Engineer

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 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)