#18193 - C# Developer

Qualitest • Kingston, Ontario, Canada • 14h ago

Job Description

Key Responsibilities

Lead the design and development of robust, scalable, and compliant C#/.NET software for a Class II medical device.
Own architectural decisions and guide implementation to align with system requirements and risk controls.
Serve as the technical liaison between software, systems, QA, regulatory, and hardware teams.
Define and enforce best practices for coding standards, documentation, version control, and software lifecycle processes.
Drive the creation of design documentation, risk assessments, and software traceability in accordance with IEC 62304.
Conduct and lead code reviews, technical walkthroughs, and root cause investigations.
Mentor junior and mid-level developers; promote a culture of engineering excellence and continuous learning.
Support verification and validation efforts, participate in hazard analyses, and ensure mitigation strategies are implemented.
Contribute to project planning, estimation, and status reporting in Agile or hybrid (Agile + V-model) environments.

Required Qualifications

Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or related discipline.
6+ years of professional software development experience with C#/.NET.
Proven experience in regulated product development, specifically Class II or Class III medical devices.
Strong understanding and practical experience with IEC 62304, ISO 14971, and FDA QSR/21 CFR Part 820.
Deep expertise in OOP, multithreading, software design patterns, and dependency injection.
Demonstrated ability to produce high-quality technical documentation and design artifacts.
Proficient in development tools such as Visual Studio, Azure DevOps, Git, and unit testing frameworks.

Preferred Qualifications

Experience developing WPF, WinForms, or cross-platform GUIs for medical or laboratory devices.
Familiarity with DICOM, HL7, Bluetooth/USB, or other healthcare communication protocols.
Exposure to cybersecurity for medical devices, including secure coding and FDA premarket cybersecurity guidance.
Hands-on experience with test automation, CI/CD pipelines, and software validation tools in regulated environments.
Experience with system-level integration, including interactions with hardware, firmware, and cloud services.

Soft Skills \& Leadership Traits

Strong communication and stakeholder engagement skills.
Proven ability to lead, mentor, and elevate team capabilities.
High level of attention to detail and a proactive approach to risk mitigation.
Comfortable working in a dynamic environment with shifting priorities and evolving regulatory expectations.

Must Haves

5+ years of professional software development experience with C#/.NET.
Proven experience in regulated product development, specifically Class II or Class III medical devices.
Strong understanding and practical experience with IEC 62304, ISO 14971, and FDA QSR/21 CFR Part 820.

Benefits

Be a part of a company who strives to support for diversity and inclusion in the workplace -- we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities.
Local and global opportunities -- we offer you internal rotation and international mobility opportunities to grow your career.
Clear view of your career and progression with the company -- Qualitest is growing massively (since 2021 -- tripled our employees base -- we now have more than 8,000 engineers) and giving you the opportunity to grow with us.
Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
Never stop experimenting and learning with QCraft -- our Learning \& Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym!
Earn bonuses via our Client Referral and Employee Referral Program's. Refer and earn -- tap your network for net-worth.
We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers' achievements.
Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless!
A Competitive pay, the salary range for the role is $90,000 - $100,000.
Intrigued to find more about us?
Visit our website at https://www.qualitestgroup.com/
If you like what you have read, send us your resume and let's start talking!

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