Senior Systems Engineer – Medical Devices & IVD Instruments

Burke Porter, an Ascential Technologies Brand•San Diego, CA

7d•$150,000 - $185,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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).
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.
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.
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.