Permanent position for a Principal Systems Engineer responsible for architecture, integration, and life cycle technical direction of regulated medical device systems spanning hardware, firmware, and clinical use environments.
Define and maintain system architectures, system-level requirements, and interface definitions across electrical, mechanical, software, usability, and clinical domains, with traceability maintained through the full product life cycle.
Lead system integration activities and resolve cross-domain technical issues across development programs.
Perform hazard analysis and risk management per ISO 14971, including risk evaluations triggered by complaints, nonconformance reports, and production trends.
Direct verification and validation strategy, including validation per IEC 62366-1 and FDA human factors guidance.
Provide system-level content for regulatory submissions, including architecture descriptions, risk traces, and verification summaries.
Review nonconformance reports and deviations, assessing system-level risk and determining the need for design or manufacturing action.
Support field actions, quality holds, and CAPA investigations requiring system-level technical coordination.
Serve as technical subject matter expert for Design Controls and systems engineering process during audits and regulatory inspections, and mentor engineers on systems engineering practice.
Requirements
BS Engineering (Systems, Biomedical, Electrical, Mechanical, or Software).
Minimum 10 years of systems engineering or product development experience on complex, regulated products.
Working knowledge of systems engineering methodology, requirements management, and system architecture development.
Working knowledge of FDA Design Controls, ISO and IEC environments and usability engineering principles.
Experience with requirements management, traceability, and model-based systems engineering tools (SysML or equivalent).
Experience contributing system-level documentation to regulatory submissions.
Experience with ECO/change control and system-level technical assessment of design updates and deviations.
Experience with post-market surveillance, complaint trend analysis, field action coordination, and system-level safety assessment.
