Principle Software Engineer

Title: Principal Software Engineer – C#/.NET | Medical Devices
Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

• Duration: Direct hire, Full-time
• Pay rate: $180,000–$200,000+ annually, DOE
• Job Location: Northborough, MA
• Work Model: Hybrid – 3 Days On-site / 2 Days Remote
• Schedule: Monday – Friday, 1^st shift
• Job ID: bh19872

Work Authorization & Location Requirements

• Candidates must be currently authorized to work in the United States without employer sponsorship, now or in the future.
• This position is not eligible for visa sponsorship, including employment under CPT or OPT authorization.
• Candidates must be able to work on-site in Northborough, MA, 3 days per week. Travel expenses will not be reimbursed.
• Relocation assistance is not available. Candidates must reside within commuting distance or be willing to relocate at their own expense.

Description:
We are seeking an experienced Principal Software Engineer to provide technical leadership in the design, development, and evolution of sophisticated software solutions within the medical device industry.

This is an opportunity for a highly skilled engineer who combines deep expertise in C#/.NET, modern web technologies, software architecture, and regulated medical device development with the ability to lead technical initiatives and mentor engineering teams.

The ideal candidate is a hands-on technical leader who can architect scalable, secure, and reliable software systems while contributing directly to development efforts. This role involves working across web applications, mobile technologies, cloud services, APIs, and connected medical devices.

You'll collaborate closely with software architects, engineering teams, product stakeholders, and UX/UI designers to shape the future of software development while ensuring compliance with medical device regulations and cybersecurity standards.

Key Responsibilities
Software Architecture & Technical Leadership

• Provide technical leadership in the design, development, and maintenance of complex software systems across a connected medical device ecosystem.
• Define and implement scalable, secure, reliable, and maintainable software architectures.
• Collaborate with software architects and development teams to establish technical direction and engineering best practices.
• Lead architectural decisions, technical design reviews, and code reviews.
• Identify opportunities to improve application performance, reliability, security, and resource utilization.
• Mentor software engineers and technical leads, promoting engineering excellence and continuous improvement.

Full-Stack Software Development

• Design and develop modern web applications, backend services, and APIs using C#/.NET and JavaScript/TypeScript technologies.
• Develop responsive, accessible, and user-friendly applications using modern front-end frameworks and web technologies.
• Apply object-oriented programming principles, software design patterns, and distributed systems architecture.
• Collaborate with UX/UI teams to translate designs and requirements into high-quality software solutions.
• Support cloud-based architectures, containerization, CI/CD pipelines, and automated testing initiatives.
• Contribute hands-on code while providing architectural guidance and technical oversight.

Medical Device Software & Regulatory Compliance

• Develop software in accordance with medical device industry standards, including IEC 62304, ISO 13485, and ISO 14971.
• Maintain software architecture documentation, design controls, traceability records, and supporting technical documentation.
• Apply secure software development lifecycle (Secure SDLC) practices and risk management principles.
• Support regulatory compliance throughout the software development and product lifecycle.

Cybersecurity & Emerging Technologies

• Champion secure-by-design development, threat modeling, vulnerability management, and software supply chain security.
• Apply cybersecurity standards and guidance, including OWASP ASVS, IEC 81001-5-1, and applicable medical device cybersecurity requirements.
• Evaluate and guide the adoption of AI-enabled and agentic technologies within regulated software environments.
• Establish appropriate safeguards, evaluation practices, and human oversight for AI-driven functionality.
• Stay current with emerging software engineering, cloud, cybersecurity, and AI technologies.

Required Qualifications

• 8+ years of professional software engineering experience, including significant involvement in software architecture and technical leadership.
• 3+ years of software development experience within the medical device industry, including familiarity with IEC 62304, ISO 13485, and ISO 14971.
• Strong hands-on experience with C#/.NET development.
• Experience developing modern web applications using HTML, CSS, JavaScript, and/or TypeScript.
• Knowledge of modern front-end frameworks, mobile application development, and backend services.
• Extensive understanding of object-oriented programming, software architecture patterns, and distributed systems design.
• Strong understanding of cybersecurity principles, secure software development, threat modeling, and vulnerability management.
• Experience with Agile development methodologies, software design controls, and regulated software development lifecycles.
• Experience with unit testing frameworks, automated testing, code quality standards, and CI/CD practices.
• Demonstrated ability to lead technical initiatives, mentor engineers, and collaborate with cross-functional development teams.
• Strong analytical, problem-solving, communication, and organizational skills.
• Bachelor's degree in Computer Science, Software Engineering, or a related discipline, or equivalent professional experience.

Additional Experience of Interest

• Cloud platforms such as Microsoft Azure, AWS, or Google Cloud.
• Containerization, Infrastructure as Code (IaC), and cloud-native development.
• Embedded software or firmware development using C/C++, RTOS, and device communication protocols.
• Hardware-in-the-loop testing and connected device integration.
• AI-enabled software development, agentic AI, retrieval systems, tool orchestration, and AI governance.
• Familiarity with ISO/IEC 42001 and the NIST AI Risk Management Framework.
• Medical device cybersecurity guidance and software supply chain security, including SBOMs.
• Modern UI/UX design principles and accessibility standards.

What We're Looking For
The successful candidate will be more than an experienced software developer. We're looking for a hands-on technical leader who can make architectural decisions, solve complex engineering challenges, and guide teams toward high-quality software solutions.

You should be comfortable balancing strategic software architecture with practical development, navigating the requirements of regulated medical device environments, and collaborating across software, hardware, product, and engineering disciplines.

Work Arrangement
This is a hybrid position based in Northborough, Massachusetts, requiring 3 days on-site and allowing 2 days of remote work each week.

Interested?
If you're an accomplished Principal Software Engineer with expertise in C#/.NET, software architecture, and medical device development, we'd love to connect.

Apply today to learn more about this opportunity.

Please use the apply button to submit your resume for consideration. You will receive a brief survey via email to complete your application. Applicants who complete the survey will receive priority consideration.

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