Job Opportunities in India
October 16, 2024
QuEST Global
FULL TIME
Subject Mater Expert- Hemodialysis Machine
Job Requirements
Work Experience
Responsibilities
The ideal candidate will have a combination of technical expertise, analytical skills, and attention to detail, as well as strong communication and collaboration skills to work effectively with a range of stakeholders.
Requirements
Must Have
Good to Have
Language Skill
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An opportunity is available with a leading Japanese medical device company for a long-term and scalable engagement. As this is a new business, the selected candidate will become a core member, contributing significantly to the company's growth.
The ideal candidate should have over eight years of hands-on experience in medical device system engineering with working experience on Hemodialysis system. Experience in defining system and sub system requirement. Designing Hemodialysis algorithms, system behaviour and control system. The role of System Engineer is to contribute in sustainable and development of a product or solution to the market, from understanding the needs of the product across regions & countries to the validation of the product changes to the regions. -
Working location Bangalore/Trivandrum and reporting to the Systems Manager.
Work Experience
Responsibilities
- 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.
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Provide system support to the development team to ensure that the project successfully meets the schedule & quality aspects throughout the project life cycle.
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Ensure detailed, high quality technical documentation to capture and communicate product changes and configurations with the necessary stakeholders.
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Actively engage with development team and other system engineers to aid in the overall integration of product changes.
The ideal candidate will have a combination of technical expertise, analytical skills, and attention to detail, as well as strong communication and collaboration skills to work effectively with a range of stakeholders.
Requirements
Must Have
- 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.
Good to Have
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Use tools such as DOORS and excels in the management of requirements and decomposition of system level requirements to modules.
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Excels in the creation of system use Cases for product or solution based on the regional demands, customers, and their local environments.
- Exposure to Usability Engineering Process
Language Skill
- English – Business level (Good communication and presentation skills required)
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