Bachelor's degree in Engineering or related field with 3+ years of progressive experience in medical device risk management or product development, including ownership of complex systems or programs.
Bachelor's degree in Engineering or related field with 3+ years of progressive experience in medical device risk management or product development, including ownership of complex systems or programs.
Senior Risk Engineer
Round Lake, IL · On-site
Bachelor's degree in Engineering or related field with 3+ years of progressive experience in medical device risk management or product development, including ownership of complex systems or programs.
Senior Risk Engineer
Round Lake, IL · On-site
Bachelor's degree in Engineering or related field with 3+ years of progressive experience in medical device risk management or product development, including ownership of complex systems or programs.
Medical Device/Combination Product Engineer
Vernon Hills, IL · On-site
$60K - $75K/yr
You'll contribute to the creation of Design History Files (DHF), risk management files, and other ... medical device and combination product consulting, staffing, and training firm. With our deep ...
Medical Device/Combination Product Engineer
Vernon Hills, IL · On-site
$60K - $75K/yr
You'll contribute to the creation of Design History Files (DHF), risk management files, and other ... medical device and combination product consulting, staffing, and training firm. With our deep ...
Medical Device/Combination Product Engineer
Vernon Hills, IL · On-site +1
$60K - $75K/yr
You'll contribute to the creation of Design History Files (DHF), risk management files, and other ... medical device and combination product consulting, staffing, and training firm. With our deep ...
Medical Device/Combination Product Engineer
Vernon Hills, IL · On-site +1
$60K - $75K/yr
You'll contribute to the creation of Design History Files (DHF), risk management files, and other ... medical device and combination product consulting, staffing, and training firm. With our deep ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
... cannot risk placing untrained personnel into a clinic or a live operating room. Consequently ... To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers ...
Principal Risk Engineer
$112K - $154K/yr
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field) * 5+ years (senior-level)experience in medical device risk management or ...
Principal Risk Engineer
$112K - $154K/yr
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field) * 5+ years (senior-level)experience in medical device risk management or ...
Principal Risk Engineer
Round Lake, IL · On-site
$112K - $154K/yr
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field) * 5+ years (senior-level) experience in medical device risk management or ...
Principal Risk Engineer
Round Lake, IL · On-site
$112K - $154K/yr
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field) * 5+ years (senior-level) experience in medical device risk management or ...
Risk Management Engineer
$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.
Risk Management Engineer
$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.
... 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 ...
... 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 ...
... 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 ...
... 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 ...
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.
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.
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 ...
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 ...
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 ...
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 ...
Ensure audit readiness and maintain risk-based documentation. * Collaborate with Quality ... Manage quality-system documentation and eMDR/FDA reporting workflows. * Provide regulatory decision ...
New
Quick apply
Ensure audit readiness and maintain risk-based documentation. * Collaborate with Quality ... Manage quality-system documentation and eMDR/FDA reporting workflows. * Provide regulatory decision ...
New
Be Seen First
Clinical Specialist Medical Device
Peoria, IL · On-site
$100 - $150/day
In conjunction with Territory Sales Manager, provide case and clinical support during product ... medical device or Operating Room experience, preferred * Gyn/Surg related experience, preferred
Quick apply
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Clinical Specialist Medical Device
Peoria, IL · On-site
$100 - $150/day
In conjunction with Territory Sales Manager, provide case and clinical support during product ... medical device or Operating Room experience, preferred * Gyn/Surg related experience, preferred
... risk, and ensure appropriate linkage to MDR, Deviation, CAPA, and continuous improvement activities. Responsibilities Include: • Manage end-to-end software medical device complaint intake ...
... risk, and ensure appropriate linkage to MDR, Deviation, CAPA, and continuous improvement activities. Responsibilities Include: • Manage end-to-end software medical device complaint intake ...
DDT Medical Device Investigation Analyst
Bannockburn, IL · On-site
$89K - $141K/yr
... risk, and ensure appropriate linkage to MDR, Deviation, CAPA, and continuous improvement activities. Responsibilities Include: Manage end-to-end software medical device complaint intake ...
DDT Medical Device Investigation Analyst
Bannockburn, IL · On-site
$89K - $141K/yr
... risk, and ensure appropriate linkage to MDR, Deviation, CAPA, and continuous improvement activities. Responsibilities Include: Manage end-to-end software medical device complaint intake ...
Medical Device Risk Management information
See Illinois salary details
$49.9K - $60.3K
4% of jobs
$60.3K - $70.8K
6% of jobs
$70.8K - $81.2K
11% of jobs
$85.1K is the 25th percentile. Wages below this are outliers.
$81.2K - $91.7K
11% of jobs
The median wage is $100K / yr.
$91.7K - $102.1K
23% of jobs
$102.1K - $112.5K
13% of jobs
$119.4K is the 75th percentile. Wages above this are outliers.
$112.5K - $123K
12% of jobs
$123K - $133.4K
8% of jobs
$133.4K - $143.9K
6% of jobs
$143.9K - $154.3K
4% of jobs
$154.3K - $164.7K
2% of jobs
$49.9K
$108.1K
$164.7K
How much do medical device risk management jobs pay per year?
Is risk management a good career?
What is the highest paying risk management job?
How much does a risk manager get paid?
What are the key skills and qualifications needed to thrive in Medical Device Risk Management, and why are they important?
What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?
| Aspect | Medical Device Risk Management | Medical Device Quality Assurance |
|---|---|---|
| Primary Focus | Identifying, evaluating, and mitigating risks associated with medical devices | Ensuring products meet quality standards and regulatory requirements |
| Certifications | ISO 14971, RAPS certifications often preferred | ISO 13485, regulatory compliance certifications |
| Work Environment | Design and development teams, risk analysis meetings | Manufacturing, inspection, and quality control departments |
| Industry Usage | Used throughout product lifecycle for safety management | Used 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 risk management in the medical device industry?
What is medical device risk management?
How does a Medical Device Risk Management professional typically collaborate with cross-functional teams during the product development lifecycle?
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Full-time
Medical, Dental, Life, Retirement, PTO
Posted 23 days ago
Job description
This is whereyour work makes a difference.
At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your Role at BaxterThe Senior Risk Engineer is responsible for leading and accomplishing risk management activities for infusion pump systems throughout the product lifecycle. This role ensures patient and user safety by identifying hazards, assessing risks, and applying effective mitigation strategies. By following corporate procedures and industry standards, the Senior Risk Engineer collaborates with engineering, quality, regulatory, clinical, manufacturing, and service teams to incorporate risk management into product build, development, and post-market activities, all in support of ongoing product safety.
What You'll Do:- Lead risk management activities following ISO 14971 and corporate procedures concerning risk management plans, hazard analyses, FMEAs, fault tree analyses, and risk reports.
- Identify hazards associated with infusion pumps, including mechanical, electrical, software, usability, and cybersecurity-related risks.
- Collaborate with cross-functional teams during the build and development to ensure risk controls are incorporated, verified, and validated.
- Ensure traceability between hazards, hazardous situations, risk controls, and verification activities.
- Perform robust risk impact assessments of issue records, change controls, complaint trends, and NCR/SNCs using appropriate severity and probability models, ensuring risks are reduced to acceptable levels.
- Update risk management files based on build changes and post-market information, ensuring ongoing product safety.
- Facilitate risk reviews and risk management team meetings.
- Train and mentor team members on risk management principles and tools.
What You'll Bring:
- Bachelor's degree in Engineering or related field with 3+ years of progressive experience in medical device risk management or product development, including ownership of complex systems or programs.
- Proven experience leading risk management activities across the product lifecycle using tools such as FMEA, FTA, and hazard analysis.
- Advanced proficiency with requirements and risk management tools (e.g., DOORS), bug tracking systems, and end-to-end traceability and documentation in regulated environments.
- Excellent analytical and data-driven decision-making skills, with the ability to independently assess risk, influence design decisions, and balance patient safety, product performance, and compliance.
- Demonstrated ability to lead and influence cross-functional teams, communicate complex risk concepts clearly, and drive alignment across engineering, quality, and regulatory stakeholders.
Join us in making a difference and ensuring the safety and efficacy of our life-saving technologies. Your expertise will help us deliver outstanding healthcare solutions!
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements.At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000- $132, 000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.