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)