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Full Time Medical Device Software Engineer Jobs in Chicago, IL

Tempus

Senior Quality Engineer

Chicago, IL · On-site

As a Senior Quality Engineer , you will: * Lead verification, validation and maintenance of host ... Be involved in the medical device software design controls activities, in accordance with the FDA ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

As a Senior Quality Engineer , you will: * Lead verification, validation and maintenance of host ... Be involved in the medical device software design controls activities, in accordance with the FDA ...

Tempus

Senior Application Security Engineer

Chicago, IL

$130K - $180K/yr

Lead specialized security testing and threat modeling for FDA-regulated medical device software ... engineering teams with hands-on remediation guidance. * Automate security testing by developing ...

Tempus

Senior Application Security Engineer

Chicago, IL · On-site

$130K - $180K/yr

Lead specialized security testing and threat modeling for FDA-regulated medical device software ... engineering teams with hands-on remediation guidance. * Automate security testing by developing ...

Intelas

Medical Device Integration Coordinator

Chicago, IL · On-site

$75K - $80K/yr

Bachelor's degree in Information Technology, Computer Science, Biomedical Engineering, Healthcare Technology Management, or a related field. * Experience with Epic, HL7, medical-device integration ...

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All JobsMedical Device Software Engineer JobsFull Time Medical Device Software Engineer JobsFull Time Medical Device Software Engineer Jobs in Chicago, IL

Full Time Medical Device Software Engineer information

See Chicago, IL salary details

$65.4K

$152K

$211.7K

How much do full time medical device software engineer jobs pay per year?

As of Aug 31, 2026, the average yearly pay for full time medical device software engineer in Chicago, IL is $151,971.00, according to ZipRecruiter salary data. Most workers in this role earn between $123,600.00 and $178,200.00 per year, depending on experience, location, and employer.

What is the difference between Full Time Medical Device Software Engineer vs Medical Software Developer?

AspectFull Time Medical Device Software EngineerMedical Software Developer
CredentialsBachelor's or higher in Software Engineering, Biomedical Engineering, or related fields; certifications like CMMI or ISO 13485 often preferredSimilar educational background; certifications less common but beneficial
Work EnvironmentDesigning, testing, and maintaining software for medical devices in regulated settingsDeveloping medical software applications, often in software companies or healthcare tech firms
Employer & Industry UsageMedical device manufacturers, healthcare equipment companiesHealthcare software companies, health tech startups

Both roles involve developing software for medical applications, but the Full Time Medical Device Software Engineer typically works within regulated environments focusing on device safety and compliance, while Medical Software Developers may work on a broader range of healthcare software solutions. The engineer role emphasizes adherence to industry standards and validation processes.

What are the most commonly searched types of Medical Device Software Engineer jobs in Chicago, IL?

The most popular types of Medical Device Software Engineer jobs in Chicago, IL are:

Full Time Medical Device Software Engineer jobs near you
Infographic showing various Full Time Medical Device Software Engineer job openings in Chicago, IL as of August 2026, with employment types broken down into 13% Internship, 69% Full Time, 6% Part Time, 6% Contract, and 6% Nights. Highlights an 88% In-person, 6% Hybrid, and 6% Remote job distribution, with an average salary of $151,971 per year, or $73.1 per hour.

Senior Quality Engineer

Chicago, IL • On-site

Tempus
See more jobs at Tempusexternal

Full-time

Re-posted 28 days ago

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.

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