BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines preferred.
5+ years of experience in FDA regulated domains (medical device, pharma, biotech).
3+ years of experience in Computer System Validation (CSV).
Familiarity with industry standards for medical device software and CSV, including Design Controls, GAMP 5, and FDA regulations.
Knowledge of quality system principles and practices in the life sciences industry.
Proven ability to deliver quality outputs with minimal supervision.
Responsibilities
Lead verification, validation, and maintenance of host systems for Tempus Medical Devices.
Conduct risk assessments to inform testing strategies.
Engage in medical device software design controls per FDA and ISO standards.
Oversee computer system validation (CSV) activities for Tempus AI applications and software tools.
Develop and maintain CSV policies, procedures, and work instructions.
Perform validation and change controls for AI, SaaS, and in-house developed software.
Collaborate with cross-functional teams to define testing strategies and execute tests.
Support compliance during internal/external inspections and audits.
Benefits
Comprehensive medical benefits.
Incentive compensation opportunities.
Restricted stock units.
Support for professional development and training.
Flexible work arrangements with a hybrid model.
Full Job Description
PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters) or Aliso Viejo, California office.
As a Senior Quality Engineer, you will:
Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).
Lead risk assessments to determine testing strategies.
Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.
Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.
Responsibilities:
Support regulatory compliance of the host system operating with Tempus Medical Device(s).
Develop and maintain CSV policies, procedures, templates and work instructions.
Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.
Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.
Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.
Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.
Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.
Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.
Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.
Qualifications
BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
3+ years experience in Computer System Validation (CSV).
Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).
Knowledge of quality system principles, practices, and standards for the life science industry.
Ability to deliver quality outputs without directions or under minimal supervision.
Chicago Pay Range: $90,000-$130,00
NYC/SF Pay Range: $100,000-$150,000
The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
About Tempus
Tempus is a technology company that has built an operating system to battle cancer. The company enables physicians to deliver personalized cancer care for patients through its interactive analytical and machine learning platform. Tempus provides genomic sequencing services and analyzes molecular and therapeutic data to empower physicians to make real-time, data-driven decisions. The company also offers research services to enable discovery of new therapeutic targets and clinical services that support clinical trial design and monitoring. Tempus was founded in 2015 by Eric Lefkofsky and has raised over $8 billion in funding to date.
