Subject Mater Expert- Hemodialysis Machine

7 days ago


Thiruvananthapuram Kerala, India QuEST Global Full time

**Job Requirements**
- 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.
- 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.

**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
- Use tools such as DOORS and excels in the management of requirements and decomposition of system level requirements to modules.
- 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)

Japanese ability - Business level / JLPT N2 or above (Reading & Writing) good to have



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