Senior Software Engineer

Position Summary

We are looking for a Senior Software Engineer to ensure the quality, safety, and compliance of our full-stack connectivity solutions for STERIS Healthcare capital products including sterilizers, washers, and automated endoscope reprocessors (AERs). This role involves executing manual and automated tests to verify the reliability, security, and regulatory compliance of the software. The ideal candidate will work closely with developers, regulatory teams, and stakeholders to ensure the system meets FDA, HIPAA, and other healthcare industry standards

Duties

• Design, develop, and execute manual and automated test cases for healthcare software handling medical device data.
• Ensure software meets FDA regulations, HIPAA, and IEC 62304 compliance requirements.
• Perform functional, usability, integration, security, and performance testing for medical data workflows.
• Develop and maintain test automation frameworks using tools like Selenium, Cypress, or NUnit.
• Validate data integrity, interoperability, and compliance for secure medical data exchange.
• Document test cases, defects, and reports following regulatory best practices.
• Work with DevOps teams to integrate automated testing into CI/CD pipelines for continuous validation.
• Participate in risk assessments, validation planning, and verification activities to meet regulatory expectations.

Duties - cont'd

Education Degree

Required Experience

Preferred Experience

1. 5+ years of Software testing experience in healthcare, medical devices, or regulated industries with knowledge of compliance standards.
2. Bachelor’s in Software Engineering or Computer Engineering required.  

Skills

1. Experience in healthcare, medical devices, or regulated industries with knowledge of compliance standards.
2. Proficiency in manual and automated testing, including API and database testing.
3. Familiarity with test management tools (e.g., TestRail) and defect tracking systems (e.g., JIRA).
4. Experience with automated testing tools such as Selenium, Cypress, or NUnit.
5. Strong understanding of data security, encryption, and PHI/PII protection.
6. Familiarity with software validation processes in regulated environments.