Principal Engineer, Systems

As a MDB leader for the Peritoneal dialysis systems the candidate will lead all the MBD activities collaborating with the cross functional teams to deliver the embedded code while meeting all the medical device regulations and standards with Aqueduct as the leading project.

Define and own the MBD framework, methodology, and governance for MATLAB/Simulink, State flow, and Embedded Coder.

Create system‑level models (plant + controller) for electro‑mechanical behaviors—motors/actuators, power stages, sensors, safety interlocks, calibration, and diagnostics.

Define modeling guidelines, libraries, and reference architectures to maximize reuse, traceability, and testability.

Translate system requirements into executable models; maintain end‑to‑end traceability (DOORS → Simulink Requirements → tests → code).

Decompose control strategies and safety requirements into model components, interfaces, and state machines.

Lead FMEA /Risk analysis (ISO 14971) and ensure design mitigations are implemented and verified in models.

Set standards for auto‑code generation (Embedded Coder, coder profiles, build settings, data types, fixed‑point).

Ensure generated C/C++ integrates cleanly with target RTOS/MCU/SoC, HAL/BSP, drivers (SPI, I2C, UART, PWM, ADC, timers), and communication stacks (CAN, Ethernet if applicable).

Enforce coding standards (e.g., MISRA‑C/C++), static analysis, and defensively designed runtime checks.

Establish model‑in‑the‑loop (MIL), software‑in‑the‑loop (SIL), processor‑in‑the‑loop (PIL), and hardware‑in‑the‑loop (HIL) strategies, including plant models for electromechanical dynamics.

Own model coverage, requirement coverage, and code coverage targets; define acceptance criteria and entry/exit gates.

Implement CI/CD for models and generated code, including automated builds, checks, and regression tests.

Ensure compliance with IEC 62304 (software lifecycle), IEC 60601 (applicable electrical safety), ISO 14971 (risk), ISO 13485 (QMS), and FDA design controls.

Lead and author deliverables: software plans, architectures, risk controls, verification protocols/reports, trace matrices, and problem reports/CAPA inputs.

Partner with Cybersecurity (FDA guidance, SBOM, vulnerability handling) and Usability Engineering (IEC 62366) where SW behavior impacts user risk.

Work with Electrical/Mechanical to co‑simulate and co‑design plant models (motors, gear trains, loads, sensors, thermal, power).

Support manufacturing test strategies (boundary tests, calibration models, digital twins) and service diagnostics.

Guide suppliers/CMs on MBD integration and compliance expectations; review artifacts from external modeling partners.

Mentor systems, software, and test engineers in MBD, control theory, and verification strategies.

Drive continuous improvement—templates, scripts, libraries, checkers, and dashboards; conduct design and model reviews.

Serve as the technical authority for trade‑offs (performance vs. safety vs. cost vs. schedule).

Master’s in Electronics and communication, Electrical and Electronics, Automation or Computers engineering or a similar field.

15 years of relevant industrial experience in model based development.

Exposure to coding standards and SW development life cycle

Expertise in design control documentation, including Design History Files.

Proven experience in technical risk assessment, mitigation, and execution.

Strong analytical skills, and trouble shooting experience in electro-mechanical devices.

Excellent written and verbal communication skills, with the ability to influence technical and business decisions at all organizational levels.

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