We are looking for Lead Engineer with 10 + Years of Experience for our esteemed client for Bangalore Location
Key Skills: EMI/EMC, Safety Lab, Testing, Medical Equipment’s per IEC 60601-1
This is an immediate requirement. Please apply if you can join within 20 days or close to 20 days.
Roles and Responsibilities:
• Perform 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.
• Assists modalities in identifying and solving Safety & EMI/EMC, Safety related issues in NPI Designs.
• Review Safety Product Test Plans & EMI/EMC Test Plans.
• Compile test results and complete Safety Test Reports for submittal to Modality Safety Leader.
• Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures.
• Oversee Safety, EMI/EMC, Environmental & Vibration, 3D Printing laboratory test equipment: Assure all equipment is operational and calibrations are current. Maintain operation of all automated equipment and test control software. Define new equipment needs per changes and additions to the test standards.
• Perform Safety, EMI/EMC, Environmental & Vibration testing of customer products per submitted Test Plans and applicable standards.
• Work with external agencies for the Certification (CTF) / accreditation (NABL) of the Lab’s.
• Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.
• Ensure Lab Technicians & Lab Engineers are trained for required skills to ensure smooth operation of the labs.
• Capture requirements from Modality teams, regulatory changes to the standards & accordingly propose the roadmap for the lab. Come up with business proposal & drive the investment.
Required Skills, Qualifications (Technical Competency):
• Bachelor’s in electrical / Electronics
• 10 + 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.
• Lead the NABL Accreditation & Certifications for EMI/EMC, Safety Lab & Environmental.
• Hands on Testing for Safety foe Medical Equipments per IEC 60601-1 & other particular standard
• Analyse the safety testing & EMI/EMC testing failures & come up with workarounds suitable for the product.
• Overlook the operations of all the Labs – EMI/EMC, Safety & Environmental.
• Ensure the Cost Savings & Utilization are inline with leadership expectations
