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 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.
QualificationsRequired- 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.
- Ability to work independently, manage multiple priorities, and collaborate effectively across disciplines.
Preferred / Plus- 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.
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Here Are Some of the Great Benefits We Offer: - Most locations offer a 9/80 schedule, providing every other Friday off
- Competitive compensation & 401(k) program to plan for your future
- Robust medical, dental, vision, & disability coverage with qualified wellness discounts
- Basic Life Insurance and Additional Life & AD&D Insurances are available
- Flexible Vacation & PTO
- 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
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
