- 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.
- 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.
Principal Systems Engineer - Medical Devices in clifton at Unknown Company
This position is listed as full time and onsite.