ZipRecruiter

Log In

1

Medical Device Computer System Validation Jobs (NOW HIRING)

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

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 ...

Tempus, Inc.

Senior Quality Engineer

Manhattan, NY · On-site

$125 - $150/hr

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 ...

Tempus

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 ...

Katalyst CRO

CSV Engineer

Redwood City, CA · On-site

Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation ... and medical device companies worldwide. Founded in , the company is headquartered in South ...

Biovire

Director, Validation

Brighton, MI · On-site

$100K - $120K/yr

Equipment, Facilities & Utilities Qualification and Computer Systems Validation. The Director will ... medical device, or another similarly regulated environment, including significant leadership ...

Deloitte

System Test and Validation Lead

Lake Mary, FL · On-site +1

... computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ ...

Deloitte

System Test and Validation Lead

Hermitage, TN · On-site +1

... computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ ...

Deloitte

System Test and Validation Lead

Tulsa, OK · On-site +1

... computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ ...

Deloitte

System Test and Validation Lead

Memphis, TN · On-site +1

... computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ ...

Deloitte

System Test and Validation Lead

Pittsburgh, PA · On-site +1

... computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ ...

Deloitte

System Test and Validation Lead

Morristown, NJ · On-site +1

... computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ ...

Deloitte

System Test and Validation Lead

Baltimore, MD · On-site +1

... computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ ...

previous page

Showing results 41-60

All JobsTechnology JobsSoftware JobsSoftware Quality Engineer JobsMedical Device Computer System Validation Jobs

Medical Device Computer System Validation information

See salary details

$10

$54

$86

How much do medical device computer system validation jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for medical device computer system validation in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What is medical device computer system validation?

Medical Device Computer System Validation (CSV) is the process of ensuring that software and computer systems used in the manufacturing, testing, or management of medical devices meet regulatory requirements and function as intended. This involves documenting that all systems are installed correctly, operate reliably, and consistently produce accurate data. CSV is critical for patient safety, product quality, and regulatory compliance, particularly with standards like FDA 21 CFR Part 11 and ISO 13485. The validation process typically includes planning, risk assessment, testing, and ongoing monitoring throughout the system's lifecycle.

What are the key skills and qualifications needed to thrive as a medical device computer system validation specialist?

To thrive as a Medical Device Computer System Validation specialist, you need a solid understanding of regulatory compliance (such as FDA 21 CFR Part 11), risk management, and computer science or engineering principles, often supported by a relevant degree or certification. Familiarity with validation protocols, quality management systems (QMS), and software tools like ALM or TrackWise is essential. Strong attention to detail, analytical thinking, and effective communication skills help ensure validation activities meet strict industry standards. These skills are vital for safeguarding patient safety, ensuring product quality, and maintaining regulatory compliance in the medical device industry.

What are some common challenges faced by professionals in medical device computer system validation and how can they be addressed?

Professionals in Medical Device Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring thorough documentation, and coordinating with cross-functional teams like IT, quality assurance, and engineering. Staying updated with current FDA guidelines and international standards (such as ISO 13485) is crucial. Clear communication and collaboration with team members can streamline validation activities and help address gaps early. Utilizing robust project management tools and maintaining organized, audit-ready documentation can also significantly reduce stress and improve efficiency.

What is the difference between Medical Device Computer System Validation vs Quality Assurance Specialist?

AspectMedical Device Computer System ValidationQuality Assurance Specialist
Primary FocusEnsuring computer systems meet regulatory and functional requirements for medical devicesMaintaining product quality through process audits and compliance
CertificationsGxP, 21 CFR Part 11, Validation certificationsISO 9001, Six Sigma, QA certifications
Work EnvironmentRegulated labs, validation teams, manufacturing settingsQuality departments, manufacturing plants, audits
Industry UsageMedical device manufacturing, regulatory submissionsProduct quality, process improvement, compliance

Medical Device Computer System Validation specialists focus on verifying that computer systems used in medical device manufacturing comply with regulatory standards. Quality Assurance Specialists oversee overall product quality and process compliance. While both roles ensure regulatory adherence, validation is specifically about system verification, whereas QA covers broader quality management.

Senior Quality Engineer

Chicago, IL • On-site, Remote

Tempus
See more jobs at Tempusexternal

Full-time

Re-posted 7 days ago

Key responsibilities

  • Lead verification, validation, and maintenance of host systems supporting Tempus Medical Device(s).

  • Lead risk assessments to determine testing strategies and support regulatory compliance of the host system operating with Tempus Medical Device(s).

  • Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies, and participating in test execution.

Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

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.

Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply