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Medical Device Risk Management Jobs in Gilbert, AZ

Shares risk management information and issues through participation in patient safety initiatives and various hospitals, medical staff and/or other similar entity-specific committees. 6. Responds to ...

Shares risk management information and issues through participation in patient safety initiatives and various hospitals, medical staff and/or other similar entity-specific committees. 6. Responds to ...

Shares risk management information and issues through participation in patient safety initiatives and various hospitals, medical staff and/or other similar entity-specific committees. 6. Responds to ...

College Medical Center Phoenix is proud to be the newest addition to College Health Enterprises. We ... The Quality Coordinator - Risk Manager supports the Director in leading, planning, and implementing ...

College Medical Center Phoenix is proud to be the newest addition to College Health Enterprises. We ... The Quality Coordinator - Risk Manager supports the Director in leading, planning, and implementing ...

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Our client is an Industry Leader in Medical Devices and this role is responsible for managing ... Previous Medical Device Monitoring is Required. To qualify, you must have monitored any of the ...

College Medical Center Phoenix is proud to be the newest addition to College Health Enterprises. We ... The Quality Coordinator - Risk Manager supports the Director in leading, planning, and implementing ...

Description ABOUT US Okland is a commercial general contractor and construction management company ... Benefits & Wellbeing Free healthcare plan option plus medical, dental, vision, life, and disability ...

ABOUT US Okland is a commercial general contractor and construction management company with more ... Benefits & Wellbeing Free healthcare plan option plus medical, dental, vision, life, and disability ...

ABOUT US Okland is a commercial general contractor and construction management company with more ... Benefits & Wellbeing Free healthcare plan option plus medical, dental, vision, life, and disability ...

Risk Management: * Lead the risk management framework, including identifying, assessing, and ... Medical with multiple different plan options. * Health Savings account + company contributions.

Description ABOUT US Okland is a commercial general contractor and construction management company ... Benefits & Wellbeing Free healthcare plan option plus medical, dental, vision, life, and disability ...

Showing results 41-60

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 Sep 9, 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 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 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:

Staff Quality Engineer - Product Development, Tempe, AZ - (IK)

Tempe, AZ • On-site

$110K - $115K/yr

Full-time

Re-posted 17 days ago


Job description

Job Responsibilities:
  • Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)
  • Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices.
  • The ability to create, support, review chemistry, manufacturing, and controls device submissions
  • Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed
  • Leads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)
  • Leads component qualifications, design validation, design verification, drug stability and process validation
  • Leads product investigations
  • Ability to make and present risked based decisions
  • Assess product changes against product design
  • Supports translation of design inputs into manufacturing control plans
  • Develop and implement procedures to comply with corporate and industry standards.
  • Coordinates and/or directs all aspects of product development activity related to a product line
  • Leads development of risk assessments and test methods
  • Quality engineering representation on Product Development and Design Review teams
  • Prepare and present project updates and technical discussions
  • Participate in project planning, budgeting, scheduling, and tracking
  • Support internal and external supplier audits
  • Provide support to the regulatory department in writing technical submissions
  • Complies with company procedures and policies, government regulations
  • Actively participates in training and providing input to training of employees on division procedures and policies
  • Ability to travel for business, project, and issues approximately up to 25% of time.
  • Other duties and projects, as assigned

Required Education and Experience:
  • BS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry
  • Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
  • Extensive proven understanding of design controls in development stage
  • Pharmaceutical or combination product experience

Required Qualifications:
  • Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
  • Ability to lead creation of risk management files
  • Ability to develop solutions with business impact
  • Advanced statistical and risk assessment techniques
  • Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
  • Ability to make and present risk-based decisions
  • Strong interpersonal skills
  • Ability to analyze and optimize manufacturing and quality systems
  • Product, design & prototyping
  • Ability to create and provide training
  • Problem solving ability
  • Ability to create, review and coordinate test protocols and reports
  • Ability to generate engineering proposals
  • Oral and written presentation skills
  • Ability to lead cross functional teams
  • Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines

Skills and Certifications
Drug Device delivery combination products
Compensation
Base Salary - USD $110,000 to $115,000
Full-time
Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Candidate Details
8+ to 10 years experience
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Ideal Candidate
8+ years experience in New Product Development of combination devices
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com