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Manager Medical Device Software Engineer Jobs in Chicago, IL

Be involved in the medical device software design controls activities, in accordance with the FDA ... Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance ...

Be involved in the medical device software design controls activities, in accordance with the FDA ... Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance ...

Software Engineering Manager This role leads a software engineering team that designs, develops ... Strong knowledge of medical device safety and software standards such as IEC, IEC, and ISO ...

Software Engineering Manager This role leads a software engineering team that designs, develops ... Strong knowledge of medical device safety and software standards such as IEC, IEC, and ISO ...

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

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 ...

Our Technical Support Representative opportunity would see you supporting a leading medical device ... or department management * Obtains and maintains proper vendor credentialing to service all ...

Senior Software Engineer

Elgin, IL ยท On-site

$121K - $159K/yr

Manage assigned projects from start to finish; for major projects reports to Project Manager or ... A minimum of 4 years of relevant work experience in the medical device field or other highly ...

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Manager Medical Device Software Engineer information

See Chicago, IL salary details

$102.5K

$174.5K

$206.5K

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

As of Jul 29, 2026, the average yearly pay for manager medical device software engineer in Chicago, IL is $174,487.00, according to ZipRecruiter salary data. Most workers in this role earn between $178,200.00 and $178,200.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Manager Medical Device Software Engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

How does a Manager Medical Device Software Engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What does a Manager Medical Device Software Engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.
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:
What job categories do people searching Manager Medical Device Software Engineer jobs in Chicago, IL look for? The top searched job categories for Manager Medical Device Software Engineer jobs in Chicago, IL are:
Sr. Manager, Medical Device Cyber Security

Sr. Manager, Medical Device Cyber Security

Tempus

Chicago, IL โ€ข On-site

$150K - $210K/yr

Full-time

Posted 22 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.
The Role
As the Medical Device Cybersecurity Senior Manager, you will own the medical device cyber security program at Tempus AI. You will act as the crucial bridge between enterprise-wide security strategy and product-level medical device technical execution. You will partner closely with R&D, Product Management, Regulatory Affairs, and Quality to integrate security into the device lifecycle ("shift-left"), ensure adherence to FDA cybersecurity guidelines, and enabling Pre-Market submissions as well as Post-Market surveillance of Tempus Medical Devices.
What You'll Do
  • Program Management & Strategy Execution:
    • Develop, implement, and continuously mature the Medical Device Cybersecurity roadmap, policies, and Standard Operating Procedures (SOPs), aligning them with the overarching enterprise data security strategy.
  • Product Security & Engineering Partnership:
    • Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development.
    • Define and manage the strategy for Software Bill of Materials (SBOM) generation and maintenance across all device product lines.
    • Coordinate with Cloud Security, Application Security, and Vulnerability Management Information Security teams to integrate their services into Tempus Medical Devices.
  • Regulatory Compliance & Quality Assurance:
    • Ensure device design and lifecycle management align with FDA pre-market and post-market cybersecurity guidelines.
    • Author, review, and maintain cybersecurity documentation required for regulatory submissions (e.g., 510(k), De Novo, PMA).
    • Coordinate with the Quality Management team to integrate cybersecurity into the enterprise Quality Management System (QMS).
  • Leadership & Mentorship:
    • Mentor, and develop the Medical Device Cybersecurity Analyst(s), guiding their daily tactical execution, vulnerability assessments, and professional growth.
    • Serve as the primary Subject Matter Expert (SME) for Medical Device Cybersecurity across the organization and provide education to cross-functional teams on the program.
  • Threat & Vulnerability Management:
    • Oversee the continuous monitoring, vulnerability scanning, and patching strategies for deployed medical devices.
    • Manage engagements with penetration testing conducting assessments on Tempus hardware and embedded systems

Qualifications
  • 7+ years of technical experience in information security in the tech or healthcare industry.
  • Deep understanding of FDA Cybersecurity Guidance (Pre-market and Post-market), ISO 14971, and ISO 13485
  • Proficiency in threat modeling methodologies (STRIDE, PASTA) and secure architecture design.
  • Industry-recognized certifications such as CISSP, HCISPP, CISM, or relevant SANS certifications are preferred.
  • Ability to manage several programs at once and work proactively to align multi-disciplinary stakeholders.
  • Excellent written and verbal communication skills, including the ability to act as translator among diverse teams of biologists, medical professionals, engineers, operators, and data scientists.

#LI-HR1
#LI-Hybrid
CHI: $150,000-$210,000
The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, 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.
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.