Systems Engineer - JR-048141

         Work with internal and external customers/stakeholders and the product development teams, collect, analyze, and translate customer needs into requirements and specifications.

         Apply System Engineering methodologies/tools (use case analysis, functional architecture design, Requirements Management in DOORs) in the product design and development cycle to ensure quality in design.

         Working on preparing the procedure documents, Design Descriptions, System Requirements Documents, Compliance to Standards, V & V documents, and FDA submissions.

         Lead the risk management activities (risk assessment and control, DFMEA, FTA, usability risk analysis, etc.) for the product.

         Understand and apply appropriate Human Factors in systems design and develop use specifications, user interface requirements, etc.) to ensure product is designed in compliant to relevant usability guidelines/standards. Conduct studies and tests to ensure system meets the HF requirements.

         Bachelor’s degree or above in science or engineering field.

         3-5 years in medical devices and Mechanical Engineering experience with relevant experience in System Engineering on Personnel health care products

         Trained / experienced in ISO 14971, IEC60601, HE 75, Human Factor Engineering, etc.

         Trained / experienced in ISO 13485 or FDA 21 CFR 820

         Certification in Systems Engineering is preferred.