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Systems Engineer

3 months ago


Orlando, United States SRI Tech Solutions Inc. Full time

Job Description

Works with marketing and/or product management to develop design input requirements from user and business needs.

Leads the generation of the system design input requirements.

Ensures tracing between user and business needs, and the design input requirements.

Makes sure design input requirements include safety risk management requirements, and human factors.

Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.

Support system architecture and design of new or next generation technologies/products

Contribute to system risk assessment activities, Use/Design FMEA activities

Supports system verification execution

Qualifications needed

BS or MS in electrical engineering, Computer Science, Biomedical Engineering or related field

Possesses systems engineering experience spanning the entire product lifecycle, including proficient use of systems engineering tools (e.g. requirements management, change control, etc.).

Systems engineering experience (at least 3 years) in a highly regulated industry

Knowledge of Software and System Architectures and design principles.

Experience using configuration management, test management, requirements management, and issue tracking systems.

Ability to lead teams through a structured approach to solving complex technical problems.

Strong knowledge of Design Controls & Risk Management practices

Strong personal credibility & excellent communication skills

Desired qualifications

Medical Device development experience with sound understanding of ISO 13485, IEC 60601, ISO 14971 Standards