*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!

RESPONSIBILITIES

  • 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.

QUALIFICATIONS

Minimum Qualifications:

  • 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.

Preferred Qualifications:

  • 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.

ABOUT EVIDATION

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.

OUR VALUES

  • 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
EVIDATION HEALTH VALUES DIVERSITY AND IS COMMITTED TO EQUAL OPPORTUNITY FOR ALL PERSONS WITHOUT REGARD TO RACE, COLOR, CREED, RELIGION, MARITAL STATUS, AGE, NATIONAL ORIGIN OR ANCESTRY, POLITICAL ACTIVITY OR AFFILIATION, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION INCLUDING GENETIC CHARACTERISTICS, MARITAL STATUS, SEXUAL ORIENTATION, GENDER IDENTITY, SEX OR GENDER.

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Evidation are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.