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Contract 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 ...

Collabera

Medical device engineer

North Chicago, IL

... days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance ... Evaluate and integrate relevant engineering advances for improving or solving problems Understand ...

Collaborative LLC

Be Seen First

Medical Device Assembly

Portland, OR · On-site

$20/hr

... o m Medical Device Assembler, 1st Shift, Portland, OR ..... Job Highlights: * 20./hour ... software packages. Ability to prioritize work by determining the sequencing and timing of different ...

New

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 ...

Trudell Medical Group

Senior Software Engineer

Elgin, IL · On-site

$121K - $159K/yr

A minimum of 4 years of relevant work experience in the medical device field or other highly ... Fluent in C programming, Assembly and other software languages with ability to support migration to ...

CACI International, Inc.

Software Engineer

Lisle, IL · On-site

Familiarity with low-level programming such as device-driver and OS programming * Understanding of ... and contract wage rates, relevant prior work experience, specific skills and competencies ...

Danaher

Software Engineer Internships

Aurora, IL · On-site

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

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All JobsContract Medical Device Software Engineer JobsContract Medical Device Software Engineer Jobs in Chicago, IL

Contract Medical Device Software Engineer information

See Chicago, IL salary details

$65.4K

$152K

$211.7K

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

As of Aug 13, 2026, the average yearly pay for contract 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 are some common challenges faced by contract medical device software engineers, and how can they be addressed?

Contract Medical Device Software Engineers often encounter the challenge of rapidly adapting to new projects, technologies, and regulatory requirements unique to each client. Working within strict timelines while ensuring compliance with FDA and ISO standards can be demanding. To address these challenges, it's important to have strong communication skills, maintain thorough documentation, and stay updated on industry regulations. Collaborating closely with cross-functional teams—including quality assurance, hardware engineers, and regulatory affairs—also helps ensure project success and smooth integration into existing workflows.

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

AspectContract Medical Device Software EngineerMedical Device Software Developer
CredentialsTypically requires a degree in software engineering, biomedical engineering, or related field; certifications like ISO 13485 or FDA compliance knowledge are commonSimilar educational background; often holds certifications in medical device regulations or quality standards
Work EnvironmentContract roles in medical device companies, often project-based, with focus on compliance and validationFull-time or freelance positions within medical device firms, focusing on software development and testing
Industry UsageCommonly hired for specific projects requiring regulatory compliance and validation expertiseInvolved in ongoing software development, maintenance, and updates for medical devices

While both roles require technical expertise in medical device software, Contract Medical Device Software Engineers typically work on short-term projects with a focus on compliance and validation, whereas Medical Device Software Developers are involved in continuous software development and maintenance within the industry.

What is a contract medical device software engineer?

A Contract Medical Device Software Engineer is a software professional who is hired on a temporary or project basis to design, develop, and test software used in medical devices. They typically work with manufacturers to ensure that the software meets regulatory standards, such as those set by the FDA or ISO. Responsibilities may include creating embedded software, documenting code, and collaborating with cross-functional teams to deliver safe and effective medical products. Their expertise is crucial for developing reliable software that supports patient safety and product compliance.

What are the key skills and qualifications needed to thrive as a contract medical device software engineer?

To thrive as a Contract Medical Device Software Engineer, you need a solid background in software development (C/C++/Python), embedded systems, and knowledge of medical device regulations such as IEC 62304, typically supported by a relevant engineering degree. Familiarity with development environments, version control (e.g., Git), and tools for requirements management and verification are essential, along with any certifications in medical device software or quality systems. Strong problem-solving skills, attention to detail, and effective communication are crucial for collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to deliver safe, compliant, and innovative software solutions efficiently in a highly regulated and dynamic industry.

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:

Contract Medical Device Software Engineer jobs near you

Senior Quality Engineer

Tempus

Chicago, IL • On-site

Full-time

Re-posted 10 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), New York, or Redwood City locations.
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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