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Our client is a pioneering medical technology organization advancing MRI-compatible solutions for cardiac ablation procedures. Known for innovation in interventional MRI environments, the company develops cutting-edge platforms that help clinicians improve procedural precision, safety, and patient outcomes while transforming the future of electrophysiology.
****Position Responsibilities:****
This role combines advanced software engineering with compliance-driven development practices within a highly regulated medical device environment. The successful candidate will contribute to the design, implementation, verification, and documentation of software solutions while ensuring alignment with quality and regulatory requirements.
* Design, develop, test, and support software features across the client's platform and related systems.
* Translate software functionality into clear, testable, and maintainable requirements.
* Create and maintain software design specifications and architecture documentation.
* Develop verification plans, traceability artifacts, and supporting compliance documentation.
* Participate in risk management activities including hazard analysis and FMEA exercises.
* Ensure consistency between requirements, implementation, testing, and release documentation.
* Collaborate with Quality Assurance and cross-functional stakeholders to support product releases.
* Identify documentation gaps and implement process improvements across engineering workflows.
* Mentor team members on requirements development, traceability, and documentation best practices.
* Participate in code reviews, technical design discussions, and complex system debugging efforts.
* Support adherence to quality system requirements and regulatory expectations.
****Position requirements:****
* 5 years of professional software engineering experience.
* Experience working within regulated industries such as medical devices.
* Strong proficiency in C#, Python, JavaScript, or similar programming languages.
* Experience developing and supporting complex integrated software systems.
* Demonstrated debugging, troubleshooting, and problem-solving capabilities.
* Ability to create clear technical documentation from software implementations.
* Experience balancing software development responsibilities with compliance documentation requirements.
* Strong communication skills and ability to collaborate across multidisciplinary teams.
****Preferred Requirements:****
* Familiarity with IEC 62304, ISO 14971, or related regulatory standards.
* Experience with requirements management and traceability processes.
* Knowledge of software design documentation including SDS and SAD deliverables.
* Experience supporting risk management documentation and verification planning activities.
* Exposure to audits, regulatory submissions, or quality system processes.
* Experience mentoring engineers and driving process improvement initiatives.
****Reasons to Apply:****
* Competitive salary plus a comprehensive benefits package.
* Health coverage, retirement plans, and other company-sponsored perks.
* Generous paid time off, including holidays, to support work-life balance.
* Flexible schedules and work life balance.
* Strong focus on employee development with on-the-job training and career growth.
* A positive company culture that values diversity and collaboration.
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