About the Role
The role involves designing, executing, and documenting software verification and validation activities for clinical diagnostic systems. The candidate will work closely with development, quality, and regulatory teams to ensure software meets all functional and compliance requirements.
Responsibilities
- Develop and maintain software validation protocols and test plans
- Execute test cases for software used in clinical diagnostic applications
- Ensure compliance with FDA, ISO, and other regulatory standards
- Collaborate with software development teams to resolve defects
- Document validation results and prepare summary reports
- Support audits and regulatory submissions
- Maintain traceability between requirements, test cases, and results
- Conduct risk assessments related to software functionality
- Review software design and development documentation
- Identify gaps in test coverage and recommend improvements
- Work within a quality management system compliant with medical device regulations
- Participate in design reviews and change control processes
- Validate software updates and patches in controlled environments
- Ensure data integrity and security in validation processes
- Train team members on validation best practices
- Manage validation timelines and deliverables
- Use version control and test management tools effectively
- Apply systems thinking to complex software workflows
- Stay current with evolving regulatory expectations
- Contribute to continuous improvement of validation processes
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model with flexibility for remote and on-site work
Team
Collaborative cross-functional team environment focused on product quality and regulatory compliance
Why This Role Matters
- This position plays a critical role in ensuring that diagnostic software delivers accurate and reliable results for patient care.
- Your work directly supports regulatory compliance and the successful deployment of life-impacting technologies.
Technology Environment
- Work with modern software stacks used in cloud-based diagnostic platforms.
- Engage with containerized applications and scalable data processing systems.
Growth Opportunities
- Opportunities to lead process improvements and mentor junior engineers.
- Potential to contribute to strategic quality initiatives across the organization.
Available for qualified candidates
