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.

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), and Software Architecture and Design Documents.
  • 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.
  • Apply and evolve software engineering best practices, including unit, integration, and system testing, static analysis, code reviews, and design reviews.
  • 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 project planning and execution.

• Cross-Functional & Customer Collaboration

  • Collaborate closely with systems, electrical, mechanical, optical, manufacturing, and quality teams to ensure alignment with system requirements and hardware constraints.
  • Work directly with customers and stakeholders to clarify requirements, resolve technical issues, and support successful product delivery.

• Emerging Technologies

  • Evaluate and responsibly integrate AI-assisted development tools (e.g., code generation, analysis, testing support) to improve productivity and quality within regulated development constraints.

Qualifications

• Required:

  • Bachelor’s degree in Computer Science, Electrical Engineering, Mathematics, or a related discipline (Master’s degree preferred).
  • 10+ years of experience developing software for complex, hardware-integrated instruments or devices.
  • Strong proficiency in C# (.NET 8+), C++, and object-oriented design.
  • Demonstrated experience developing software for motion-controlled and/or fluidics-based instruments.
  • Proven experience working within a regulated software development lifecycle (Agile, Spiral, or hybrid models).
  • Hands-on experience with IEC 62304, ISO 13485, and FDA 21 CFR Part 820, including software risk and hazard analysis.
  • Experience with version control and work item tracking systems such as Git and Azure DevOps.
  • Demonstrated technical leadership or software team leadership experience.
  • Strong written and verbal communication skills.
  • Able to work independently, manage multiple priorities, and collaborate effectively across disciplines.

• PREFERRED / PLUS EXPERIENCE:

  • Experience with software estimation, project planning, and schedule forecasting.
  • Familiarity with desktop UI frameworks (e.g., WPF or WinForms).
  • Experience working directly with external customers or partners.
  • Experience implementing static analysis tools, automated testing, and CI/CD pipelines in regulated environments.
  • Experience evaluating or using AI tools for software development, including responsible use within compliance frameworks.

Benefits

• Competitive compensation & 401(k) program
• Robust medical, dental, vision, & disability coverage with qualified wellness discounts
• Basic Life Insurance and Additional Life & AD&D Insurances are available
• Paid Parental Leave
• Generous Employee Referral Program
• Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
• Voluntary Tricare Supplement available for military retirees