Staff Systems Engineer
Core
Lead major systems-engineering workstreams, guiding technical strategy, integration, and lifecycle management for complex regulated products.
Role type
Staff Systems Engineer (via careerplan.io/jobs/ga96fef8-staff-systems-engineer-at-organ-recovery-systems-inc)
Builds
Complex electromechanical, software-enabled, connected, or multidisciplinary regulated products (medical devices strongly preferred)
Domain
Medical Devices / Regulated Engineering / Systems Engineering
Required skills
Systems engineering lifecycle management, Requirements decomposition and traceability, Risk integration (ISO 14971), Verification and validation planning, Cross-functional technical leadership, Root-cause analysis, Change impact assessment, Technical decision-making, Stakeholder needs definition, Architecture and interface definition
Preferred skills
Jama Connect proficiency, Design control training, Arena PLM/QMS familiarity, SOLIDWORKS/PDM, GitHub Enterprise, Power BI, Regulatory submission support
Technologies
Jama Connect, Arena PLM/QMS, GitHub Enterprise, SOLIDWORKS/PDM, SharePoint/Microsoft 365, Smartsheet, Power BI
Responsibilities
Lead systems-engineering workstreams and technical strategy; Develop and maintain stakeholder needs, requirements, and verification methods; Lead functional decomposition, interface definition, and trade studies; Maintain end-to-end traceability among needs, requirements, and verification; Lead complex investigations and change-impact assessments; Coordinate across R&D, Quality, Regulatory, and Manufacturing; Lead training and development of reusable methods and templates; Configure and govern Jama Connect information architecture and workflows.
Seniority
Staff, hands-on IC with major leadership impact
