Senior Software Verification & Validation Engineer

The Senior Software Verification and Validation Engineer is responsible for planning, developing, executing, and documenting software verification and validation activities for embedded software used in ASP capital systems. This role supports manual and automated testing, requirements-based verification, defect investigation, field issue investigation support, testing lab maintenance, and release readiness in a regulated medical device environment. The position works closely with Software Engineering, Systems Engineering, Quality, Regulatory, Manufacturing, Service, and other cross-functional teams to ensure ASP software products meet applicable requirements, quality expectations, and compliance standards. This position reports to the Senior Manager, Software Engineering at ASP USA. 

Responsibilities 

Under limited supervision and in accordance with applicable laws, regulations, ASP policies, procedures, and quality system requirements, this position is responsible for the following: 

• Create, execute, and maintain manual and automated software test cases, test scripts, and test procedures to ensure comprehensive verification coverage for embedded systems. 

• Develop and recommend new test methods, tools, and strategies to improve product robustness, reliability, and overall software quality. 

• Analyze system-level and software-level requirements to define effective verification strategies and ensure requirements traceability. 

• Prepare verification and validation documentation for software releases, including test plans, protocols, reports, summaries, and objective evidence. 

• Analyze test results, document anomalies, support defect investigations, and provide recommendations on potential sources of software or system-level issues. 

• Support field issue investigations by reviewing customer-reported problems, service data, logs, test results, and related documentation to help identify potential software, system, or configuration-related causes. 

• Work collaboratively with cross-functional teams, including Software Engineering, Systems Engineering, Quality, Regulatory, Manufacturing, Service, and Field Service, to investigate, reproduce, troubleshoot, and document field issues and support timely resolution. 

• Maintain the software verification and validation testing lab, including test systems, equipment, configurations, software versions, tools, fixtures, and lab documentation to ensure test readiness and reproducibility. 

• Collaborate with cross-functional teams, including Software Engineering, Systems Engineering, Quality, Regulatory, Manufacturing, and Service, to support product development, issue resolution, and release activities. 

Required Qualifications 

• Bachelor’s degree in computer engineering, Computer Science, Electrical Engineering, or a related technical discipline. 

• 3-5 years of experience in embedded software testing, system-level testing, or software verification and validation. 

• Experience performing system integration testing, subsystem testing, and requirements-based verification for embedded or connected systems. 

• Strong knowledge of software verification and validation methodologies, including writing test cases, test plans, test protocols, and test reports. 

• Working knowledge of computing software, operating systems, networking concepts, and IT infrastructure relevant to embedded or capital equipment systems. 

• Experience with scripting or programming languages, such as Python, for test automation, data analysis, or tool development. 

• Experience using defect tracking, requirements management, or test management tools such as JIRA, Azure DevOps, Polarion, Jama, or equivalent tools. 

• Proficiency with Windows and Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook. 

• Strong analytical, problem-solving, interpersonal, and written communication skills. 

• Self-motivated, detail-oriented, and able to work independently and collaboratively in a cross-functional environment. 

Preferred Qualifications 

• Experience working in a regulated medical device software environment, including familiarity with IEC 62304, ISO 13485, FDA design controls, or equivalent quality system requirements. 

• Experience with risk-based testing, requirements traceability, software risk analysis, cybersecurity verification, or validation documentation for regulated products. 

• Experience using electronics test equipment such as multimeters, oscilloscopes, function generators, logic analyzers, or similar tools. 

• Experience working in Agile, Scrum, or Lean software development environments.