Medical Device Software Testing Jobs in California

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.
Fortive Corporation Overview
Fortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to advanced technologies that help providers focus on exceptional patient care.
We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential-your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.
Fortive: For you, for us, for growth.
About Advanced Sterilization Products
ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP's mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP's products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.
We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
Bonus or Equity
This position is also eligible for bonus as part of the total compensation package.
Pay Range
The salary range for this position (in local currency) is 101,200.00 - 169,050.00