Position Summary
The Senior Systems Engineer owns system-level integration, requirements management, and design verification for complex electromechanical and fluidic instruments across in vitro diagnostic (IVD) and human-use medical device programs. This role brings deep experience with FDA submissions to ensure system architecture, requirements, and verification strategy support a robust, compliant, and manufacturable product. The role is expected to support an ongoing portfolio of related development programs (for example, dialysis and other extracorporeal therapies, diagnostic analyzers, drug-delivery systems, and additional complex instrument platforms). The Senior Systems Engineer partners closely with chemical, mechanical, electrical, software, and human factors engineering to integrate subsystems into a cohesive, safe, and effective instrument, while providing technical leadership and credible client interface throughout each program.
Key Responsibilities
System Architecture & Integration
- Define and maintain the system architecture, integrating fluidic, chemical, mechanical, electrical, optical, software, and user-interface subsystems into a unified instrument platform.
- Own system-level requirements development and flow-down to subsystem teams, ensuring full bidirectional traceability through requirements management tools.
- Lead system-level design reviews, interface control, and risk analyses (ISO 14971) across the full product lifecycle.
- Identify and resolve system-level integration issues, trade-offs, and technical risks across the relevant use environments (e.g., clinical, point-of-care, or home settings).
Requirements Management & Design Verification
- Develop comprehensive sets of product requirements from user needs, commercial, and regulatory inputs.
- Develop and execute system-level verification and validation strategies and protocols, ensuring requirements are objectively demonstrated to be met.
- Own design-history-file contributions related to system requirements, architecture, and verification per 21 CFR 820.30 and ISO 13485.
- Partner with Human Factors to integrate usability engineering (IEC 62366) findings into system requirements and risk controls.
- Support software (IEC 62304) and electrical (IEC 60601/61010) subsystem teams in ensuring system-level compliance and integration.
Technical Leadership & Client Interface
- Serve as the primary technical point of contact for system-level questions from clients, regulatory bodies, and executive stakeholders.
- Lead technical strategy discussions on regulatory pathway (510(k) vs. De Novo) implications for system design and evidence generation.
- Present system architecture, requirements, and verification status at design reviews, client meetings, and milestone gates.
- Mentor engineers across disciplines on systems engineering practices, requirements writing, and verification planning.
Cross-Functional Collaboration
- Partner with process- and materials-focused engineering colleagues to translate process chemistry and active-material performance requirements into system-level specifications.
- Partner with Mechanical Engineering on consumable and instrument interface requirements, tolerances, and verification methods.
- Coordinate with Regulatory Affairs and Quality to align system documentation with submission strategy and QMS requirements.
- Support clinical and human factors teams in defining use-related risk controls and system-level usability requirements.
Qualifications
Required
- BS in Systems, Biomedical, Electrical, or Mechanical Engineering; MS or PhD preferred.
- 8+ years of systems engineering experience (or 5+ years with a PhD) in IVD or human-use medical devices, including complex electromechanical or fluidic systems.
- Direct, hands-on experience supporting FDA 510(k) and De Novo submissions, including familiarity with predicate strategy, special controls, and evidentiary requirements.
- Deep knowledge of design controls (21 CFR 820.30, ISO 13485) and risk management (ISO 14971).
- Proven experience owning system requirements, architecture, integration, and verification for complex, multi-disciplinary devices.
- Proficiency with requirements management tools and V&V planning/execution.
- Strong leadership, written/verbal communication, and client-facing skills; demonstrated ability to represent technical strategy credibly to clients and executives.
Preferred
- Familiarity with IEC 60601/61010 (electrical safety), IEC 62304 (software lifecycle), and IEC 62366 (usability engineering).
- Experience with optical systems and components, thermal management, actuators and sensors, and control systems.
- Experience with home-use, portable, or wearable medical devices, including associated risk and usability considerations.
- Proficiency with AI tools. Experience with dialysis, infusion or drug-delivery systems, diagnostic instrumentation, or other extracorporeal or complex fluidic medical device platforms.
This position in an on-site role at our San Diego location. Salary range of $150,000-$185,000 plus benefits, PTO, 401k with matching.