Systems Engineer

• Define system architecture across a highly complex, multi-disciplinary product platform encompassing electrical, mechanical, robotics, optical, fluid handling, and controlled environment subsystems. Develop system-level specifications and design descriptions that drive coherence across all domains.
• Architect critical interfaces between software-driven subsystems — including embedded software, application software, and cloud software interfaces — to ensure flawless integration and function across the full system.
• Own requirements management end-to-end.
• Lead hazard analysis and risk management activities in accordance with ISO 14971, to proactively identify and mitigate risks across the systems architecture.
• Drive system-level test strategies, including test specifications and protocols, to ensure the product meets all performance, safety, and regulatory standards across areas such as statistical process control, data integrity, cybersecurity, computer system validation, cleanroom qualification, pharmaceutical grade water production qualification, container integrity testing, and automated visible particle inspection.
• Guide cross-functional design teams spanning electrical, mechanical, robotics, optics, software, and manufacturing engineering, and collaborate with program management to balance design goals including performance, cost, size, weight, and manufacturability.
• Support design controls throughout the product lifecycle, contributing to DHF documentation, design reviews, and traceability matrices consistent with project and regulatory requirements.
• Provide expert guidance to manufacturing teams, contributing to process development through PFMEA reviews and supporting the transition from development to scalable manufacturing.
• Support program management by estimating engineering effort, identifying technical risks, and ensuring project plans align with technical and regulatory milestones.

• Education: BS or MS in Systems Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• Experience: Minimum of 2+ years in a new product development environment, with a demonstrated track record of defining system architectures for novel products to achieve regulatory approval and commercialization. Medical device experience strongly preferred.
• Multi-domain systems knowledge spanning two or more of the following: electrical/electronics, mechanical design, robotics, optical systems, fluid handling, WFI generation systems, controlled environments (ISO 5/ISO 7 cleanrooms), particle inspection, embedded software, application software, and cloud software interfaces.
• Regulatory fluency: Working knowledge of FDA design controls (21 CFR Part 11, 210, 211, 820), ISO 13485, ISO 14971 risk management, IEC 62304 software lifecycle, and IEC 61010 electrical safety standards as applied to medical devices.
• Requirements engineering: Proven ability to define, manage, decompose, and verify system and subsystem requirements using industry-standard tools (e.g., DOORS, Polarion, Jama, or equivalent).
• Risk and reliability analysis: Hands-on experience conducting FMEA, DFMEA, PFMEA, hazard analysis, and fault tree analysis in a regulated product development environment.
• Verification & validation: Experience developing and executing system-level test strategies, protocols, and reports, including the application of statistical methods (e.g., sampling plans, tolerance analysis, DOE).
• Technical leadership: Demonstrated ability to guide and influence cross-functional teams without direct authority, driving alignment across engineering, quality, regulatory, and program management stakeholders.
• Communication skills: Detail-oriented with strong written and verbal communication skills; able to clearly document and present complex technical concepts to diverse audiences including regulatory bodies.

• Experience with cleanroom environments, ISO 5/ISO 7 qualification, and particle inspection systems.
• Familiarity with WFI (Water for Injection) generation and fluid handling system design in a pharmaceutical or medical device context.
• Experience with robotics system integration in a regulated product environment.
• Exposure to cloud-connected medical device architecture and cybersecurity considerations (FDA guidance on cybersecurity, IEC 81001-5-1).
• Familiarity with model-based systems engineering (MBSE) methodologies and tools (e.g., SysML, Cameo).

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