We are looking for System Engineer for our client in Santa Clara, CA
Job Title: System Engineer
Job Location: Santa Clara, CA
Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire
- Define application requirements and prepare written specifications in DOORS; break down high level feature requirements and use case specifications into functional requirements to an appropriate level of detail suitable for use by verification testers.
- Ensure system requirements analysis is performed to assure program objectives and system-level requirements are met. Define quality attributes, external interfaces, constraints, and other non-functional requirements.
- Lead peer reviews and inspections of requirements documents to ensure that the requirements are interpreted correctly. Manage requirements traceability information and tracks requirements status throughout the project.
- Lead cross-functional teams in risk management activities. Perform risk identification and complete use error risk analysis (uFMEA) and design risk analysis (dFMEA).
- Guide team members in impact analysis of defects and enhancements from a risk perspective including impact to requirements, failure modes, and mitigation.
- Proficient in the use of ISO14971risk management methodologies and medical device regulations and international standards (EU MDR, ISO13485, IEC 60601, 21 CFR 820.30 etc.)