*Considering candidates in San Mateo, Santa Barbara, or US based remote*
The Senior Software Validation Engineer at Evidation will work closely with the product, delivery, QA automation, and Health Outcomes Research teams to develop, implement, and support software and data verification & validation activities. You will assist with the development of software requirements, develop testing methods and test cases, and ensure that requirements/test acceptance criteria are met by verifying product functionality and performance, through a variety of manual and automated testing methods. You will perform validation activities to confirm data integrity across various platforms and processes, ensuring data completeness, consistency, and report accuracy. You may also support design control activities including risk management, and internal automated system validation (e.g., off-the-shelf and configurable Quality Management System databases and tools).
Successful performance contributes to a well-maintained Quality Management System comprising software tools and products that are well-documented, tested, validated, and reliable. If you have a passion for quality and detail, and want to join a team that is accelerating ways to discover medical treatments by engaging participants in real-word evidential trials, we would love to hear from you!
- Design verification & validation protocols for the study and data platforms, including data ingest, reporting, and other IT infrastructure throughout life cycle phases. Determine how these protocols should be tailored according to the unique needs and scope of each clinical trial study.
- Analyze & review clinical trial participant workflows and infer data collection and subsequent report needs to develop & build corresponding test cases based on provided software design, workflow specifications, and data ingest, utilizing both positive and negative testing processes, to thoroughly evaluate nominal and edge cases.
- Design and implement methods of verifying reports and newly ingested and processed data sources across a complex workflow.
- Create and execute test plans & protocols, manage deviations, prepare reports; as needed lead testing efforts on complex projects.
- Develop configuration data that exercise QA automation tooling so that positive and negative test cases are exercised according to the developed clinical trial participant use-case test matrices.
- Manage the testing portion of the study platform software development lifecycle, including: Jira workflow management, queueing up relevant tests and environments, ensuring tests are executed and passing before new code is deployed, while maintaining effective communication channels within and across departments.
- Create required project deliverables related to testing: test plan, test procedures, test scripts, and completed acceptance test/test reports with resolution of deviations.
- Communicate all observed defects to the technical and product leads, update test cases based on the discovered defects, and re-execute test cases accordingly.
- Adhere to internal quality processes including good documentation practices.
- Ensure schedules are executed on time and required compliance levels are achieved.
- Cooperate and respectfully communicate with external and internal customers.
- Undergraduate university degree in Computer Science, Computer Engineering or similar.
- 6+ years experience as a software validation engineer with healthcare/medical domain knowledge.
- Meticulous and detail-oriented. Ability to consistently meet critical deadlines.
- Software requirements analysis experience, including evaluation of system interfaces and traceability.
- Experience with developing and executing software verification and validation plans, protocols, and reports on software systems and complex databases as part of an Agile development life cycle.
- Well-versed in Agile development methods and tools, such as Jira and Confluence.
- Experience with manual and automated test techniques, and tools such as Test Director, TestRails, and Test Cafe.
- Experience with defect management and working closely with Software Engineers on defect resolution.
- Knowledge of approaches to verify medical device software or pharmaceutical automated systems in accordance with regulations and common industry practices.
- Ability to follow Standard Operating Procedures (SOPs), as well as written and verbal instructions.
- Demonstrated conceptual thinking by recognizing key actions and underlying problems and making connections and seeing patterns.
- Demonstrated analytical thinking by anticipating obstacles, breaking problems apart systematically, coming to logical conclusions, and seeing consequences and implications.
- Demonstrated initiative by persisting in problem-solving and proposing feasible solutions proactively.
- Extensive experience with cloud-based system engineering.
- Experience with software validation processes in medical device or pharmaceutical industries, including validation for 21 CFR Part 11, and creation of associated documentation.
- Experience with compliance issues and testing related to HIPAA.
- Proficiency at gathering test requirements and developing test scripts. Solid understanding of positive and negative testing practices. Ability to recognize deviation from accepted practice.
- Experience developing pipelines or data manipulation tools with Ruby or Python.
- Experience conducting root cause analysis and investigations of software defects.
- Ability to work independently, as well as in a team environment, under established deadlines.
- ASQ CSQE.
- Outstanding written and verbal communication skills.
Evidation measures health in everyday life and enables anyone to participate in groundbreaking research and health programs. Built upon a foundation of user privacy and control over permissioned health data, Evidation's Achievement platform is trusted by millions of individuals—generating data with unprecedented speed, scale, and rigor. We partner with leading healthcare companies to understand health and disease outside the clinic walls. Guided by our mission to enable and empower everyone to participate in better health outcomes, Evidation is working to bring people individualized, proactive, and accessible healthcare—faster.
- Put individuals first
- Challenge each other and state your good intent
- Go fast while maintaining quality and integrity
- Work to win together
OUR BENEFITS & PERKS
- Competitive salary + performance bonus + equity
- Medical, dental, and vision benefits with generous company contribution
- Company-provided life and disability insurance
- 401(k) with company contribution
- Wellness and wearable device reimbursements, mental health benefits, wellness programs
- Employee advisory committee focused around diversity, equity, inclusion, and belongingness
- Distributed teams and flexible work hours
- Take time when you need it: 13 paid company holidays + flexible time off
- Paid parental leave
- Mobile phone, home internet, and home office furniture reimbursements
- Apple laptop and your choice of monitor + noise cancelling headphones
- LinkedIn Learning and other professional growth opportunities