Senior Software Engineer
Pune, MH, IN, 411002
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
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, implement, debug, and execute software tests according to corporate policies and business operating procedures on new and sustaining engineering projects.
- Perform testing artifact development and reviews (requirements, risk controls, test plans, test design, automation strategies, protocols/test scripts, Trace Matrix, and reports) to identify issues and provide actionable recommendations.
- Define and perform test approaches for embedded systems, including data validation, model behavior testing, performance monitoring, robustness, functional, integration, and regression testing.
- Accelerate testing using AI and Machine Learning techniques, such as intelligent test case generation, test prioritization, anomaly detection, predictive defect analysis, and automated analysis of logs, metrics, and test results to improve test efficiency, coverage, and cycle time.
- Work with DevOps teams to integrate automated testing into CI/CD pipelines for continuous validation.
- Collaborate with cross-functional and Onsite/Offshore teams to plan, execute, and deliver verification activities within project schedules and quality objectives.
- Provide technical guidance and mentorship to team members on verification methods, tools, and best practices.
Duties - cont'd
Education Degree
- Bachelor's Degree in Computer Science or Engineering General
Required Experience
- Minimum 5+ years of progressive engineering experience in software and/or firmware development and verification, with a strong focus on embedded software testing
- Bachelor’s degree in Electrical Engineering, Electronics Engineering, Computer Engineering, or related engineering discipline with demonstrated software education/training.
- Hands‑on experience validating software running on embedded Linux distributions (e.g., Yocto-based systems) and/or RTOS environments.
- Experience with IoT product validation and network-related testing (device connectivity, protocols, scalability, latency, security, and reliability).
- Knowledge of software development and verification standards (e.g., IEEE series, IEC 62304) and their application.
- Experience in the medical device industry or other regulated industries with formalized SDLC, software risk management, and design controls.
Preferred Experience
Test Automation Skills
- Strong experience designing and developing test automation scripts (using PyTest, Robort framework) for embedded, system, and application-level testing.
- Proficiency in scripting/programming languages such as Python (preferred), Perl, or equivalent for automation and tooling.
- Hands-on experience integrating automation into CI/CD pipelines (e.g., automated test execution, reporting, and failure triage) development.
- Familiarity with hardware-in-the-loop (HIL), software-in-the-loop (SIL), or simulator-based test automation for embedded systems.
Linux & Embedded Software Testing Skills
- Strong understanding of Linux OS fundamentals: processes/threads, memory management, file systems, networking, and permissions.
- Hands-on experience with command-line tools, shell scripting, and remote debugging over SSH.
- Understanding of device drivers, inter‑process communication (IPC) mechanisms, and interaction between application and hardware layers.
- Experience testing performance, reliability, boot time, resource utilization, and fault handling in resource-constrained embedded environments.
Skills
- Experience in healthcare, medical devices, or regulated industries with knowledge of compliance standards.
- Proficiency in manual and automated testing, including API and database testing.
- Familiarity with test management tools (e.g., TestRail) and defect tracking systems (e.g., JIRA).
- Experience with automated testing tools such as Selenium, Cypress, or NUnit.
- Strong understanding of data security, encryption, and PHI/PII protection.
- Familiarity with software validation processes in regulated environments.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.
STERIS strives to be an Equal Opportunity Employer.
Pune, MH, IN, 411002
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Test Engineer, Testing, Embedded, Medical Device, Infection Control, Engineering, Technology, Healthcare