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.

Work Experience

• 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.