Subject Mater Expert - Hemodialysis Machine
- Quest Global
- 10 - 20 years
- Chennai
- 9 months ago
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Job Description
Job Requirements- Understand client requirements
- Design and develop Hemodialysis system and sub system.
- Identify and define internal and external customer needs/requirements for product or solution with thorough knowledge of system and product understanding.
- Provide Regulatory support on standards like IEC60601-2-16, IEC 60601-1, ISO 13485, ISO 14971, etc.
- Provide system support to the development team to ensure that the project successfully meets the schedule & quality aspects throughout the project life cycle.
- Ensure detailed, high quality technical documentation to capture and communicate product changes and configurations with the necessary stakeholders.
- Actively engage with development team and other system engineers to aid in the overall integration of product changes.
- Bachelor's degree in relevant field (CS/Electrical/Bio medical)
- Systems Engineer with 8-12 Years of experience in medical device domain.
- At least 4 years of experience in Hemodialysis system.
- Experience in Medical Device development, FDA Regulations and MDR.
- Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
- Experience in defining the algorithms for Hemodialysis system
- Experience in control system and hydraulic engineering.
- Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.
Job Classification
Industry: Medical Devices & EquipmentFunctional Area / Department: Engineering - Hardware & NetworksRole Category: HardwareRole: Design Team LeadEmployement Type: Full timeContact Details:
Company: Quest GlobalLocation(s): Chennai
Keyskills: dialysis iso devices configuration subject iec nursing teaching engineering system support patient care electricals nephrology system medical devices dressing machine hemodialysis integration project life cycle design control control system technical documentation hospital
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