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Medical Device Risk Management Jobs in Tennessee

LanceSoft

Packaging Engineer II - Exempt

Memphis, TN · On-site

Experience implementing risk mitigation actions with knowledge of packaging or process Risk ... Experience in sterile packaging and medical device packaging development. * Project management ...

LivaNova

Director - Product Security

Nashville, TN · On-site +1

$225K - $235K/yr

This executive will lead a dedicated team to manage the cybersecurity posture of our medical device ... Oversee a rigorous threat modeling program and lead cybersecurity risk assessments for all new and ...

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$46.7K

$101.3K

$154.3K

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

As of Jun 6, 2026, the average yearly pay for medical device risk management in Tennessee is $101,250.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,700.00 and $117,100.00 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.
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Medical Device Risk Management jobs near you
Quality Manager (Medical Device)

Quality Manager (Medical Device)

MRINetwork

Knoxville, TN • On-site

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Quality Manager

Medical device manufacturer in the greater Knoxville, TN area has an immediate opening for a Quality Manager. This is a smaller company that develops and manufactures complex equipment for use in hospital settings. This Quality Manager will be responsible for handling 3rd party audits and ensuring 21 CFR Part 820 regulations are met. The company has a strong Quality program in place with zero findings from the FDA on their last audit. The company wants to continually improve the Quality program to ensure all details are addressed. Qualified candidates will have a BS degree along with at least 5 years Quality experience working with Medical Device manufacturers. Ideally looking for a Quality Manager who has strong experience leading 3rd party audits. Currently, there will not be anyone reporting directly to the Quality Manager, but that could eventually change. The main focus is finding a Quality Manager with strong skills leading audits and ensuring compliance with 21 CFR Part 820 and ISO 13485. Excellent company culture with good work / life balance. Relocation assistance is available.

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