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Medical Device Risk Management Jobs in Gilbert, AZ

Aptyx

Quality Manager- MED DEVICE ISO13485

Tempe, AZ · On-site

Ensure all Device History Records (DHRs), Device Master Records (DMRs), and validation ... Provide quality input into production planning, risk management, and decision-making * Candidates ...

LivaNova

Manager, Enterprise Risk Management

Phoenix, AZ

$110K - $150K/yr

... Enterprise Risk Management is responsible for overseeing and coordinating the organization ... Health benefits - Medical, Dental, Vision * Personal and Vacation Time * Retirement & Savings Plan ...

CMC Phoenix

PI/Risk Management Manager

Phoenix, AZ

$40 - $50/hr

College Medical Center Phoenix is proud to be the newest addition to College Health Enterprises. We ... The Performance Improvement/Risk Management Manager supports the Director in leading, planning, and ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Gilbert, AZ

Medical Device Risk Management information

See Gilbert, AZ salary details

$51.3K

$111.2K

$169.5K

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

As of Jun 14, 2026, the average yearly pay for medical device risk management in Gilbert, AZ is $111,200.00, according to ZipRecruiter salary data. Most workers in this role earn between $89,700.00 and $128,600.00 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 job categories do people searching Medical Device Risk Management jobs in Gilbert, AZ look for? The top searched job categories for Medical Device Risk Management jobs in Gilbert, AZ are:
Medical Device Risk Management jobs near you

Quality Engineer(Must Have Risk, Project Management & Medical Device) - Urgent Need

millenniumsoft

Tempe, AZ • On-site

$69K - $89K/yr

Contractor

Posted 27 days ago

Job description

Position : Quality Engineer(Must Have Risk, Project Management & Medical Device) - Urgent Need
Location : Tempe, AZ
Duration : 6 Months Contract
Total Hours/week : 40.00
1st shift
Description:
  • Quality Engineering is responsible for product and service quality evaluation and control.
  • Works cross-functionally in the development and or maintenance of products or services.
  • The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
  • Demonstrates basic knowledge of quality engineering policies, principles and best practicesDemonstrates basic knowledge of FDA/ISO requirements
  • Applies basic statistical sample size calculations to work for quality determination on simple projects
  • Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervisionWrites test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
  • Has basic knowledge of theories, practices and procedures in a job family or skill
  • Applies knowledge and skills to complete own work Depends on others for instruction, guidance and direction
  • Develops competence in own area by performing routine work.

Education & Skills:
  • BS or MS degree.
  • What are the top 3 skills and or experience, required? Medical device experience, risk management experience, strong organizational/project management skills
  • Medical device experience with a strong preference for candidates with new product development experience.

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