Location: San Francisco, San Mateo, Santa Barbara, Remote
Evidation Health is a new kind of health and measurement company that provides the technology and guidance to understand how everyday behavior and health interact. The volumes of behavior data generated from wearables and smartphones has opened up new ways to analyze individuals’ behavior and health in real time. With a virtual pool of 3 million research participants, Evidation Health undertakes research for innovative biopharma and healthcare companies to transform how diseases are identified, treated, and monitored.
The 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 procedures. This role will assist with the development of software requirements, develop test cases for requirements, and ensure that requirements are met by verifying product functionality and performance. You will also support design control activities including risk management.
- 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 of each clinical trial study.
- Analyze & review clinical trial participant workflows and infer data collection and subsequent reports.
- Develop & build corresponding test cases based on provided software design, workflow specifications,and data ingest. Utilize positive and negative testing processes.
- Configure data that exercises QA automation tooling to develop positive and negative test cases clinical trial participant use-case test matrices.
- Design and implement methods of verifying reports.
- Create required project deliverables related to testing: test plan, test procedures, test scripts, and completed acceptance test/test reports.
- Lead the execution of testing plans & protocols and manage 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.
- Create and present final reports of completed validation protocols with resolution of deviations.
- Adhere to internal quality processes including good documentation practices.
- Ensure schedules are executed on time and required compliance levels are achieved.
- Undergraduate university degree required, engineering preferred.
- 5+ years experience as a software validation engineer with pharmaceutical or life sciences domain knowledge.
- Experience with SDLC and QA life cycle in a FDA compliant environment e.g. 21 CFR Part 11, including execution of validation tests and creation of associated documentation.
- Experience validating software in a highly regulated environment (such as FDA).
- Software requirement analysis.
- Developing and executing software verification plans, protocols, and reports. Defect management and resolution.
- Evaluation of system interfaces, operational requirements, and performance requirements.
- Ability to work independently, as well as in a team environment.
- Proficiency at gathering test requirements and developing test scripts. Solid understanding of positive and negative testing practices. Ability to recognize deviation from accepted practice.
- Demonstrated conceptual thinking by recognizing key actions and underlying problems; making connections and seeing patterns.
- Analytical thinking by anticipating obstacles, breaking problems apart systematically and coming to logical conclusions by seeing consequences and implications.
- Follow Standard Operating Procedures (SOPs)
- Meticulous and detail-oriented. Ability to consistently meet critical deadlines.
- Experience with defect tracking systems.
- Health, dental, and vision benefits for you and competitive coverage for your family
- Flexible work hours
- Open vacation policy - take time when you need it
- Support for remote work when needed
- Relaxed work environment
- Your choice of computing equipment and gear
- Lots of opportunities for growth
- Opportunity to work on fascinating challenges that improve people’s lives