Principal Software Engineer – Medical Instrumentation

Job Summary:

We are seeking a Principal Software Engineer to lead the architecture, design, and development of complex, regulated medical device software.

In this role, you will work hands on with embedded and desktop software systems that control sophisticated electromechanical medical instruments, contributing directly to products that improve patient health and outcomes.
This position is ideal for a principal level technical leader who thrives on solving difficult system level problems, setting technical direction, and mentoring engineers.

You will collaborate closely with systems, electrical, mechanical, optical, and manufacturing engineers and play a key role in ensuring software solutions meet regulatory, safety, quality, schedule, and cost objectives.
We offer a culture that values technical excellence, ownership, pragmatic problem solving, and continuous improvement, where principal engineers are trusted to influence architecture, process, and execution across projects.

Responsibilities:


* Technical Leadership & Software Development
+ Architect, design, implement, and deliver high‑quality embedded and desktop software for complex electromechanical medical instruments, including systems involving motion control and fluidics.
+ Set technical direction and architectural standards for software across projects, ensuring scalability, maintainability, and long‑term product sustainability.
+ Serve as a technical leader and mentor, guiding software design decisions, code quality, and engineering best practices.
+ Drive software architecture and implementation using object‑oriented design principles and modern C# (.NET 8+) and C++.


* Regulatory, Risk, and Quality
+ Create, review, and maintain regulated software documentation, including:
+ Software Development Plans (SDP)
+ Software Configuration Management Plans (SCMP)
+ Software Architecture and Design Documents


* Actively participate in software risk management and hazard analysis, integrating software contributions into system‑level risk files.


* Support Software Change Control Boards (SCCB), including defect investigation, root cause analysis, and corrective/preventive actions.


* Ensure compliance with IEC 62304, ISO 13485, and FDA 21 CFR Part 820 throughout the software lifecycle.

SDLC, CI/CD, and Continuous Improvement


* Apply and evolve software engineering best practices, including:



* Unit, integration, and system testing


* Static analysis


* Code reviews and design reviews


* Automated build and CI/CD pipelines

Develop software within an Agile or Spiral SDLC framework appropriate for regulated medical device development.

Continuously improve development processes by recommending tools, automation, and workflow enhancements, including helper scripts and productivity tooling.

Provide software effort, schedule, and cost estimates to support p...