Senior Systems Architect - Life Sciences & Medical Devices

Ascential Medical and Life Sciences (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 – System Architecture to lead the development of complex instrument architectures across fluidics, optics and imaging, motion, mechanics, electronics and software.

You will decompose user needs, run trade studies, design bench tests, and define interfaces to enable robust, scalable and manufacturable platforms for life-science and medical devices, partnering with the broader engineering team.

Qualifications

• MS in Systems, Biomedical, Electrical, or Mechanical Engineering required; PhD preferred.
• 7+ years of systems engineering experience in IVD or medical devices, including complex electromechanical or fluidic systems.
• Experience defining system architectures, interface control documentation, and conducting trade studies for complex, multi-disciplinary devices.
• Working knowledge of design controls (21 CFR 820.30, ISO 13485) and risk management (ISO 14971).
• Familiarity with architectural or functional modeling approaches (SysML, state machines, etc.).
• Hands-on experience designing and executing bench-top or prototype testing and characterization studies.

Responsibilities

• Lead development and evolution of system architecture for complex, multi-disciplinary instruments, translating user needs and product requirements into candidate architectures.
• Conduct trade studies and architectural analyses to balance performance, cost, manufacturability, and risk.
• Design and execute bench-top experiments, breadboard and prototype builds, and characterization studies to generate engineering data.
• Plan and lead early feasibility and proof-of-concept testing across architecture options, translating results into go/no-go decisions.
• Analyze test data to validate architectural assumptions and refine system-level requirements and margins.
• Define and maintain system-level interface control documentation across subsystems and technologies.
• Model system behavior using architectural modeling techniques (functional block diagrams, SysML).
• Develop platform architecture strategies for reuse and scalability across product configurations.

Skills

Systems thinking

Architecture trade studies

Bench-top testing

Cross-functional leadership

Communication to stakeholders

Risk analysis (ISO 14971)

Education

MS in Systems/Biomedical/Electrical/Mechanical Engineering

PhD preferred

Tools

SysML

Job description

Ascential Medical & Life Sciences in San Diego seeks a Senior Systems Engineer – System Architecture to lead the development of complex instrument architectures across fluidics, optics and imaging, motion, mechanics, electronics and software.

You will decompose user needs, run trade studies, design bench tests, and define interfaces to enable robust, scalable and manufacturable platforms for life-science and medical devices, partnering with the broader engineering team.