Software Engineering Manager – Medical Devices

Software Engineering Manager Medical Devices

Location: Toronto, Ontario, Canada
Employment Type: Full-Time, Permanent
Work Arrangement: Primarily Onsite
Industry: Medical Devices / Healthcare Technology

About the Opportunity

We are seeking an experienced and hands-on Software Engineering Manager to join an innovative medical technology organization developing advanced, life-saving medical devices.

This is an exciting opportunity for a technically strong engineering leader who is passionate about developing high-quality software solutions for regulated medical technologies.

The successful candidate will lead a team of software engineers, drive software architecture and development, and oversee the complete software development lifecycle-from concept and design through testing, commercialization, and ongoing product enhancement.

Working closely with senior technology leadership and cross-functional engineering teams, you will play a critical role in delivering reliable, scalable, and compliant medical device software.

Key Responsibilities

• Lead, mentor, and manage a team of software engineers, providing technical direction, coaching, and performance guidance.

• Oversee the complete software development lifecycle, including requirements analysis, architecture, design, development, integration, verification, validation, and deployment.

• Provide hands-on technical guidance in software architecture, coding, debugging, troubleshooting, and code reviews.

• Design and develop robust software applications using C#, C++, WPF, MVC, and .NET Framework.

• Lead the development and integration of PC-based software applications across Windows and Linux environments.

• Collaborate with embedded software, hardware, systems engineering, quality assurance, and regulatory teams.

• Ensure software development activities comply with applicable medical device standards, including IEC 62304 and IEC 82304.

• Support software documentation, design controls, risk management, verification, and validation activities.

• Establish and improve software development processes, coding standards, automated testing, and CI/CD pipelines.

• Manage project schedules, engineering resources, technical priorities, and software deliverables.

• Identify and resolve complex technical challenges throughout product development and commercialization.

• Drive continuous improvement in software quality, maintainability, performance, and reliability.

Required Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, or a related discipline.

• 10+ years of experience in commercial medical device software development.

• 3 5 years of direct people management experience leading software engineering teams.

• Strong hands-on software development experience using C#, C++, WPF, MVC, and .NET Framework.

• Proven expertise in software architecture, object-oriented design, system integration, debugging, and code reviews.

• Experience developing PC-based applications for Windows and Linux operating systems.

• Strong understanding of embedded software integration and hardware-software interfaces.

• Experience with source control systems such as Git/GitLab and modern CI/CD practices.

• Knowledge of test-driven development, automated testing, software verification, and validation.

• Familiarity with DICOM standards and medical imaging software.

• Working knowledge of regulated medical device software development, including:

  • IEC 62304 Medical Device Software Lifecycle

  • IEC 82304 Health Software Product Safety

  • ISO 13485 Medical Device Quality Management Systems

  • IEC 60601 Medical Electrical Equipment

  • ISO 14971 Medical Device Risk Management

• Understanding of applicable FDA, Health Canada, and international medical device regulations.

• Demonstrated ability to manage engineering teams, deliver projects, and collaborate effectively with multidisciplinary stakeholders.

Preferred Qualifications

• Experience with Avalonia UI Framework.

• Background in medical imaging, patient monitoring, diagnostic systems, or other sophisticated medical device technologies.

• Experience developing software for devices integrating sensors, embedded controllers, and user-facing applications.

• Experience working in an innovative, fast-paced medical technology or product development environment.

• Strong technical documentation and regulatory audit support experience.

What Makes This Opportunity Exciting?

• Contribute to the development of innovative, life-saving medical technologies.

• Lead a talented engineering team working on sophisticated software and hardware-integrated products.

• Influence software architecture, engineering practices, and technical strategy.

• Work closely with senior technology leadership in a collaborative environment.

• Make a meaningful impact on products designed to support healthcare professionals and patients worldwide.

Apply Now

If you are an experienced Software Engineering Manager with a strong background in medical device software development, C#, C++, WPF, .NET, and regulated software engineering, we would welcome the opportunity to connect.

Apply with your updated resume to explore this confidential leadership opportunity.

Only shortlisted candidates will be contacted.