Senior Systems Engineer leading system engineering activities within Life Cycle Engineering for innovative medical devices. Collaborating with cross-functional teams to ensure compliance with strict regulations.
Responsibilities
Lead and contribute to the definition, integration, and characterization of innovative product content
Drive system engineering activities within Life Cycle Engineering
Perform functional analysis, timeline analysis, and detailed trade-off studies
Troubleshoot system-level issues and perform root cause analysis
Develop, author, and execute comprehensive test plans, protocols, and reports
Provide technical support and expertise to cross-functional teams for post-market surveillance
Requirements
Bachelor of Science or higher in Engineering (e.g., Biomedical, Electrical, Mechanical, Systems) or related field
4+ years of experience working in the medical device industry/ highly regulated product development industry
6+ years of experience working directly in a Systems Engineering discipline
Proficiency in system-level design and requirements management
Solid understanding of medical device regulations (FDA QSR, ISO 13485) and risk management (ISO 14971)
Experience with requirements management software (e.g., Jama, Polarion, Doors)
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