Position Summary - Senior Systems Engineer – System Architecture
The Senior Systems Engineer leads the development of system architecture for life science instrumentation, medical devices, and analogous consumer and commercial applications. This role focuses on decomposing user needs and product requirements into candidate system architectures, evaluating design alternatives and trade-offs, and establishing interface definitions that enable fluidics, optics and imaging, precision motion, mechanical, electronics and controls, software, data analysis, GUI/user interface, and human factors engineering to design and integrate their subsystems effectively. The skill set is intended to support a broad, ongoing portfolio of related development programs across the life-science and medical device space (for example, diagnostic and analytical instruments, laboratory automation and point-of-care testing platforms, drug-delivery systems, extracorporeal therapies such as dialysis, and other complex instrument platforms). The Senior Systems Engineer partners closely with the broader engineering team to ensure platform architectures are robust, scalable, and manufacturable across product configurations and use environments.
Key Responsibilities
System Architecture Development
- 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 (e.g., centralized vs. distributed control, platform vs. point-solution, make/buy) to select architectures that balance performance, cost, manufacturability, and risk.
- Design and execute bench-top experiments, breadboard and prototype builds, and characterization studies to generate the engineering data needed to evaluate candidate architectures and de-risk key technical decisions.
- Plan and lead early feasibility and proof-of-concept testing across competing architecture options, translating results into go/no-go recommendations and architecture refinements.
- Analyze test and characterization data (e.g., statistical analysis, sensitivity and tolerance analysis, failure and margin analysis) to validate architectural assumptions and refine system-level requirements and performance margins.
- Define and maintain system-level interface control documentation across fluidic, reagent/assay, optics and imaging, precision motion, mechanical, electronics and controls, software, data analysis, GUI/user interface, and human factors subsystems.
- Model system behavior and performance using architectural or functional modeling techniques (e.g., functional block diagrams, state machines, SysML), grounded in test and characterization data, to validate architecture decisions prior to detailed design.
- Develop platform architecture strategies that enable reuse and scalability across a portfolio of related products and configurations (e.g., acute-care and home-use variants).
Requirements & Design Support
- Support development and flow-down of system requirements to subsystem teams, ensuring architecture decisions are reflected in requirements and traceability.
- Partner with Systems Engineering on risk analysis (ISO 14971), safety architecture, and fault tree/FMEA activities tied to architectural decisions.
- Provide architectural input into design reviews, verification planning, and design-control documentation per 21 CFR 820.30 and ISO 13485.
- Feed test, characterization, and data-analysis results back into requirements, models, and design-control documentation to keep architecture decisions grounded in engineering evidence.
Technical Leadership & Client Interface
- Serve as a technical resource on system architecture and interface strategy for engineering leadership and clients.
- Present architecture options, trade-study results, and recommendations at design reviews and client meetings.
- Mentor engineers on systems thinking, architectural modeling, and interface definition practices.
Cross-Functional Collaboration
- Partner with mechanical, electronics and controls, software, data analysis, GUI/user interface, optics and imaging, precision motion, and human factors engineering to align subsystem architectures with system-level interfaces and constraints.
- Partner with fluidics, reagent/assay, and surface-chemistry engineering to ensure system architecture reflects their process and materials requirements.
- Coordinate with Systems Engineering and Regulatory Affairs to ensure architecture decisions support the overall verification and submission strategy.
- Support Operations and Supply Chain in evaluating architectural decisions for manufacturability and sourcing implications, across internal and external manufacturing.
Qualifications
Required
- 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, with a demonstrated focus on system architecture development.
- 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 (e.g., functional block diagrams, state machines, SysML, or similar).
- Hands-on experience designing and executing bench-top or prototype testing and characterization studies, and analyzing the resulting data (e.g., statistical, sensitivity, or tolerance analysis), to inform architecture and design decisions — this role is grounded in real engineering work, not a paper-only exercise.
- Strong communication skills, with demonstrated ability to explain architectural trade-offs to both technical and non-technical stakeholders.
Preferred
- Experience supporting FDA 510(k) or De Novo submissions.
- Familiarity with IEC 60601 (electrical safety), IEC 62304 (software lifecycle), and IEC 62366 (usability engineering).
- Experience developing platform architectures intended to support multiple product configurations or use environments (e.g., clinical, point-of-care, or home settings).
- Experience across multiple life-science or medical device application areas (e.g., diagnostics, laboratory automation, drug delivery, extracorporeal therapies such as dialysis, or other complex fluidic instrument platforms).
- Experience leveraging AI-based tools (e.g., generative design, simulation, or AI-assisted requirements and systems-engineering analysis) to support architecture development and trade studies.
This is an on-site role at our San Diego location. Salary range: $150,000-$185,000 plus benefits, PTO, and 401k with matching