Senior Systems Engineer – Medical Devices & IVD Instruments

Ascential Technologies (Instruments and Devices); San Diego (CA); On-site; USD 150,000 - 185,000; Full time

Job summary

Ascential Medical & Life Sciences in San Diego seeks a Senior Systems Engineer to own system-level integration, requirements management, and design verification for complex IVD and medical device programs. You will coordinate cross-functional teams to ensure compliant, manufacturable architectures.

The role requires FDA submissions experience, design controls expertise, and strong leadership to guide subsystems from concept to verification and validation.

Qualifications

• BS in Systems/ Biomedical/ Electrical/ Mechanical Engineering; MS/PhD preferred.
• 8+ years of systems engineering in IVD or human-use medical devices.
• Direct experience with FDA 510(k) and De Novo submissions.
• Deep knowledge of design controls (21 CFR 820.30) and ISO 13485.
• Proven ability to lead requirements, architecture, integration, and verification.

Responsibilities

• Define and maintain system architecture integrating subsystems.
• Own system-level requirements and traceability.
• Lead system-level design reviews, interface control, and ISO 14971 risk analyses.
• Resolve integration issues across use environments.

Skills

Systems engineering

FDA submissions

Requirements management

V&V planning

Leadership

Client interface

Education

BS in Systems/Biomedical/Electrical/Mechanical Engineering

MS or PhD preferred

Tools

Requirements management tools

V&V tooling

Job description

Senior Systems Engineer – Medical Devices & IVD Instruments

• Full-Time
• On-site

Locations

Showing 1 location

Ascential Medical & Life Sciences
San Diego, CA 92127, USA

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

• 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.

Equal Opportunity Employer
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