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Medical Device Risk Management Jobs in Chicago, IL

Medline

Risk Management Engineer

Northfield, IL

$79K - $119K/yr

... medical devices, cosmetics, and OTC drugs. Responsible for managing an automated risk-based ... Complete device life cycle experience related to design, production, use of a device, and ISO 14971.

DQS

Contract Medical Device Lead Auditor

Schaumburg, IL · On-site

... risk management principles such as ISO 14971. * Passed or ability to pass an accredited 40-hour ISO 9001 or ISO 13485 lead auditor course. * Experience in implementation of ISO 13485, MDD and/ or ...

Medline

Risk Management Engineer

Northfield, IL · On-site

$79K - $119K/yr

... medical devices, cosmetics, and OTC drugs. Responsible for managing an automated risk-based ... Complete device life cycle experience related to design, production, use of a device, and ISO 14971.

Collabera

Medical device engineer

North Chicago, IL · On-site

... days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance ... Participate in project planning, design reviews and risk assessments using formal risk analysis ...

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Showing results 1-20

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Chicago, IL

Medical Device Risk Management information

See Chicago, IL salary details

$53.1K

$114.9K

$175.1K

How much do medical device risk management jobs pay per year?

As of Sep 9, 2026, the average yearly pay for medical device risk management in Chicago, IL is $114,919.00, according to ZipRecruiter salary data. Most workers in this role earn between $92,700.00 and $132,900.00 per year, depending on experience, location, and employer.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a medical device risk management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.

What are the key skills and qualifications needed to thrive in medical device risk management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What are popular job titles related to Medical Device Risk Management jobs in Chicago, IL?

For Medical Device Risk Management jobs in Chicago, IL, the most frequently searched job titles are:

What job categories do people searching Medical Device Risk Management jobs in Chicago, IL look for?

The top searched job categories for Medical Device Risk Management jobs in Chicago, IL are:

What cities near Chicago, IL are hiring for Medical Device Risk Management jobs?

Cities near Chicago, IL with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Chicago, IL as of September 2026, with employment types broken down into 100% Full Time. Highlights an 50% In-person, and 50% Remote job distribution, with an average salary of $114,919 per year, or $55.2 per hour.

Medical Device Systems Engineer

North Chicago, IL

Sterling Engineering Inc.
See more jobs at Sterling Engineering Inc.external

$55 - $60/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 20 days ago

Key responsibilities

  • Lead and coordinate Use-Related Risk Analysis (URRA) activities across assigned medical device and combination product programs.

  • Facilitate cross-functional meetings and collaborate with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams to identify hazards, use errors, risks, and mitigations.

  • Support key systems engineering activities, including system architecture, user needs, product requirements, traceability, risk management, and change management.

Job description

Job Title: Medical Device Systems Engineer
Location: North Chicago, IL
Hire Type: Long-Term Contract (1+ year)
Target Pay Rate: $55.00 – $60.00/hour
Work Schedule: Onsite Monday-Friday
Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), & ESOP

Job Summary:
Seeking a Systems Engineer to support the development of innovative medical devices and therapeutic combination products within a highly regulated R&D environment. This role will primarily focus on Use-Related Risk Analysis (URRA) while also supporting broader systems engineering activities, including Design Inputs, Risk Management, Traceability, Systems Integration, and Design History File (DHF) architecture. The Systems Engineer will coordinate cross-functional risk assessments for drug delivery systems such as on-body devices, pre-filled syringes, autoinjectors, mixing devices, and electromechanical pumps, partnering closely with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams throughout clinical and commercial development.

Must Have Skills:
  • 3–5 years of experience in pharmaceutical, medical device, combination product, or another regulated industry.
  • Hands-on experience with Use-Related Risk Analysis (URRA), Human Factors, or Risk Management.
  • Strong experience with Design Controls and Design History File (DHF) documentation in a regulated environment.
  • Experience working in a cross-functional, matrixed organization with strong communication and facilitation skills.

Job Duties:
  • Lead and coordinate Use-Related Risk Analysis (URRA) activities across assigned medical device and combination product programs.
  • Facilitate cross-functional meetings and collaborate with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams to identify hazards, use errors, risks, and mitigations.
  • Support key systems engineering activities, including system architecture, user needs, product requirements, traceability, risk management, and change management.
  • Develop and maintain Design Control documentation and Design History Files (DHF) in accordance with applicable regulations and internal procedures.
  • Support risk assessments, including URRA, Design FMEA, and Process FMEA activities.
  • Monitor project schedules, milestones, risks, and deliverables; escalate issues and delays as needed.
  • Support integration of third-party development activities, including vendor communications and deliverable reviews.
  • Drive consistent execution of systems engineering and risk management processes and identify opportunities for improvement.

Qualifications:
  • BS in Engineering, Science, or a related technical discipline with 5+ years of relevant experience, or MS with 3+ years of experience.
  • 3–5 years of experience in pharmaceutical, medical device, combination product, or another regulated industry.
  • Experience with Use-Related Risk Analysis, Human Factors, Risk Management, and/or product development.
  • Strong experience with Design Controls and Design History File (DHF) management.
  • Working knowledge of systems engineering principles, including requirements definition, traceability, risk management, product architecture, and change management.
  • Experience with applicable regulatory standards such as FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, or EU MDR.
  • Strong organizational, facilitation, communication, and analytical skills.
  • Ability to influence cross-functional teams, manage competing priorities, and work effectively in a highly matrixed environment.
  • Experience with project tracking/document management tools and third-party vendor coordination preferred.
  • Experience supporting drug delivery systems, medical devices, or combination products preferred.


Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.