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Medical Device Risk Management Jobs in Chicago, IL

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.

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.

Trinity Health

Risk Manager

Berwyn, IL · On-site

$78K - $121K/yr

Act as a liaison to administration, management and hospital/ambulatory care staff to provide ... Participate in and/or coordinate medical device event investigations and coordinate responses to ...

Collabera

Medical device engineer

North Chicago, IL

... 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 ...

Medline

Sr Engineer Risk Management

Northfield, IL · On-site

$92K - $138K/yr

Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls ... a quality or risk management system. * Work with Subject Matter Experts (SMEs) to create a ...

Medline

Sr Engineer Risk Management

Northfield, IL

$92K - $138K/yr

Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls ... a quality or risk management system. * Work with Subject Matter Experts (SMEs) to create a ...

US Surgitech Inc

Be Seen First

Independent Medical Device Sales Representative

Carol Stream, IL · Remote

... preferably medical device) * Confident presence and strong influencing skills; excellent ... Demonstrated proficiency in managing complex sales cycles typically defined as six months or longer ...

US Surgitech Inc

Be Seen First

Independent Medical Device Sales Representative

Carol Stream, IL · Remote

... preferably medical device) * Confident presence and strong influencing skills; excellent ... Demonstrated proficiency in managing complex sales cycles typically defined as six months or longer ...

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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 Jun 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 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 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 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 May 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/Combination Product Engineer

Medical Device/Combination Product Engineer

Ventura Solutions LLC

Vernon Hills, IL • On-site, Remote

$60K - $75K/yr

Other

Medical, Dental, Vision, PTO

Posted 9 days ago

Job description

We are seeking passionate and driven Medical Device/Combination Product Engineers to join our medical device consulting team. This is an ideal opportunity for recent graduates or those with limited experience who are excited to apply their academic knowledge in real-world product development.

If you have a strong interest in medical devices, pharmaceuticals, and combination products, and are eager to gain hands-on experience in product development, design controls, and risk management, we want to meet you!

As a Medical Device/Combination Product Engineer, you will support the development and maintenance of medical devices and combination products by assisting with technical documentation, testing, and cross-functional collaboration. You’ll contribute to the creation of Design History Files (DHF), risk management files, and other engineering documentation in accordance with industry regulations and standards such as FDA 21 CFR 820 and ISO 14971.

Responsibilities

  • Assist in developing and maintaining Design History Files (DHF) and Risk Management Files for medical devices and combination products
  • Support product development activities, including gathering user needs, design inputs, and testing requirements
  • Participate in risk assessment activities, such as creating or supporting FMEAs
  • Help prepare and review technical documentation for design verification and validation
  • Research applicable regulations, standards, and guidance documents to support compliance efforts
  • Work closely with cross-functional teams, including Quality, Regulatory, Manufacturing, Human Factors, and Clinical
  • Contribute to design control activities and help ensure traceability from requirements through testing
  • Support documentation for inspections and regulatory submissions

Qualifications

  • Bachelor’s degree in Biomedical Engineering or related engineering discipline (e.g., Mechanical, Chemical, Electrical)
  • Strong academic foundation in engineering principles and a desire to apply them in a regulated industry
  • Understanding of or exposure to design control, risk management, and product development lifecycle through coursework, internships, or academic projects
  • Strong written and verbal communication skills
  • Detail-oriented with good documentation and organizational skills
  • Team-oriented with a willingness to learn and grow in a fast-paced environment

Preferred (Not Required) Experience

  • Internship, co-op, or project work related to medical devices, drug delivery, or combination products
  • Familiarity with standards like ISO 13485, ISO 14971, or FDA design control regulations
  • Exposure to tools such as FMEA, DHF documentation, or verification test planning
  • Experience with engineering software (CAD, Minitab, MATLAB, etc.)

Location

  • Northwest Chicago Suburbs or remote for the right candidate

Employee Type

  • W2 Employee

Compensation and Benefits

  • Salary: $60,000 - $75,000 annually, depending on experience
  • Choice of medical, dental, and vision plans
  • Paid Vacation Time
  • Competitive base salary

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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