UNAVAILABLE
Senior Staff Engineer, Systems - San Diego
UNAVAILABLE, San Diego, California, United States, 92189
Overview
Position Summary: The senior staff Systems Engineer works with the development team by applying an interdisciplinary approach to the successful definition, development, integration, and testing of complex in vitro diagnostic systems. They will document user requirements, develop system requirements, participate in product architecture and design, drive risk analysis, and support integration and testing for new product introductions. The salary range for this position is currently $170,000- $200,000 annually. Individual compensation is based on the candidate’s qualifications, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs. Responsibilities
Key Accountabilities Essential Functions: Provide technical leadership to project teams. Responsible for the development of the system requirements documentation and overall requirements management. Apply architectural and design skills to work with senior development engineers to decompose the System Requirements into a structured hierarchy of sub-systems and interfaces. Create system architecture documentation. Participate in development activities, such as performing hazard and risk analysis, assisting with requirements and design, and attending design reviews. Work with product management and marketing to define user needs. Drive system integration, optimization, and root cause analysis with the development team during system integration, Alpha testing, and device pre-Beta testing. Use statistical methods such as Design for Six Sigma (DfSS) and Design of Experiments (DoE) to increase product robustness and reliability. Lead risk management activities (e.g., Design Risk Analysis) in accordance with ISO14971. Ensure compliance with design‑control regulations (21CFR820.30), ISO13485, and IVDR throughout the product lifecycle. Work with the testing team to develop strategies for system level product integration and testing, including software, electrical, analytic, and mechanical aspects of the system. Support the clinical team as needed to ensure a structured approach to product validation. Create work breakdown structures as needed. May create verification reports and overall verification summary. Demonstrate excellent written and verbal communication skills. Qualifications
Minimum Knowledge & Experience Required: BS/BA degree in CS, CE, EE, Biomedical or related engineering discipline required; MS/ME degree preferred. 10+ years industry experience. Experience in the full development lifecycle with at least one product required. Experience in Medical device development or other Regulated industry required. Experience with FDA Class II or III medical devices, including submission support (510(k) or PMA) preferred. Proven familiarity with ISO13485 quality management systems and design control best practices. Skills & Capabilities: Experience applying DOE to systems under development. Experience in the application of Human Factors is desired. Experience leading system verification activities. Experience in testing analog and digital/real-time embedded devices. Good communication and presentation skills. Good team player and leader. Comprehensive knowledge of 21CFR Part 820 and ISO14971 risk management processes. Proficiency with requirements management tools (e.g., Jama, DOORS).
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Position Summary: The senior staff Systems Engineer works with the development team by applying an interdisciplinary approach to the successful definition, development, integration, and testing of complex in vitro diagnostic systems. They will document user requirements, develop system requirements, participate in product architecture and design, drive risk analysis, and support integration and testing for new product introductions. The salary range for this position is currently $170,000- $200,000 annually. Individual compensation is based on the candidate’s qualifications, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs. Responsibilities
Key Accountabilities Essential Functions: Provide technical leadership to project teams. Responsible for the development of the system requirements documentation and overall requirements management. Apply architectural and design skills to work with senior development engineers to decompose the System Requirements into a structured hierarchy of sub-systems and interfaces. Create system architecture documentation. Participate in development activities, such as performing hazard and risk analysis, assisting with requirements and design, and attending design reviews. Work with product management and marketing to define user needs. Drive system integration, optimization, and root cause analysis with the development team during system integration, Alpha testing, and device pre-Beta testing. Use statistical methods such as Design for Six Sigma (DfSS) and Design of Experiments (DoE) to increase product robustness and reliability. Lead risk management activities (e.g., Design Risk Analysis) in accordance with ISO14971. Ensure compliance with design‑control regulations (21CFR820.30), ISO13485, and IVDR throughout the product lifecycle. Work with the testing team to develop strategies for system level product integration and testing, including software, electrical, analytic, and mechanical aspects of the system. Support the clinical team as needed to ensure a structured approach to product validation. Create work breakdown structures as needed. May create verification reports and overall verification summary. Demonstrate excellent written and verbal communication skills. Qualifications
Minimum Knowledge & Experience Required: BS/BA degree in CS, CE, EE, Biomedical or related engineering discipline required; MS/ME degree preferred. 10+ years industry experience. Experience in the full development lifecycle with at least one product required. Experience in Medical device development or other Regulated industry required. Experience with FDA Class II or III medical devices, including submission support (510(k) or PMA) preferred. Proven familiarity with ISO13485 quality management systems and design control best practices. Skills & Capabilities: Experience applying DOE to systems under development. Experience in the application of Human Factors is desired. Experience leading system verification activities. Experience in testing analog and digital/real-time embedded devices. Good communication and presentation skills. Good team player and leader. Comprehensive knowledge of 21CFR Part 820 and ISO14971 risk management processes. Proficiency with requirements management tools (e.g., Jama, DOORS).
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