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.
