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Medical Device Risk Management Jobs (NOW HIRING)

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Senior Quality Engineer

Norcross, GA · On-site

$83K - $113K/yr

Minimum of 5 years medical device experience in Quality or R&D Engineering position with risk management, design control and product development experience. * Experience in the IVD industry ...

iTech US, Inc.

Senior Medical Device Engineer

Blue Ash, OH · On-site

$96K - $131K/yr

Senior Medical Device Engineer PLM / Lifecycle Management Location: Blue Ash, OH Duration: 6+ ... Strong understanding of design controls, change management, risk management, process validation ...

BEPC INC

Medical Device Assembler

Irvine, CA · On-site

$17 - $19/hr

Medical Device Assembler Location: Irvine, CA 92614 Employment Type: W2 Contract | 6 Months with ... Support Quality Management System (QMS), Environmental Management System (EMS), and applicable ...

Hologic

Quality Engineer 4 - Risk Management

San Diego, CA · On-site

$76K - $98K/yr

Strong knowledge of medical device and/or IVD risk management principles across the full product lifecycle. * Advanced understanding of applicable regulatory and quality system requirements ...

System One

Medical Device Assembler

Lakewood, NJ · On-site

$16/hr

Notify managers of any broken pieces * Work with quality control team to ensure devices are properly assembled Medical Device Assembler Requirements: * Good hand-eye coordination * Ability to work in ...

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Medical Device Risk Management information

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$51.5K

$111.6K

$170K

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 the United States is $111,556.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,000.00 and $129,000.00 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.

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Cities with the most Medical Device Risk Management job openings:

What states have the most Medical Device Risk Management jobs?

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What are popular job titles for Medical Device Risk Management?

Popular job titles for Medical Device Risk Management:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $111,556 per year, or $53.6 per hour.

Product Risk Management Engineer

Flagstaff, AZ • On-site

W. L. Gore & Associates, Inc.
See more jobs at W. L. Gore & Associates, Inc.external

Full-time

Posted 11 days ago

Key responsibilities

  • Own product line risk management files and maintain documentation in accordance with ISO 14971 and regulatory requirements.

  • Support technical investigations and problem-solving efforts to address product or process issues and improve product performance.

  • Partner with development teams to ensure quality management system documentation and assess risks from design and manufacturing changes.

W. L. Gore & Associates rating

8.9

Company rating: 8.9 out of 10

Based on 80 frontline employees who took The Breakroom Quiz

8th of 547 rated manufacturers

Job description

Product Risk Management Engineer
Req Id: 2110
State/Province: Arizona
Business: Gore Medical Products
Category: Engineering, Scientists & Technicians
Sub-Category: Engineering
Work Arrangement: Hybrid, On-site
Posting Start Date: 8/27/26
Posting End Date: 9/11/26
About the Role
We are looking for experienced Product Risk Management Engineer (PRME) to join our engineering team supporting commercial manufacturing and new product development. In this role, you will lead and facilitate risk assessments, guide risk-based product and manufacturing process development, and utilize quality system data to make risk-based decisions to ensure product safety.
The PRME contributes to the development and maintenance of compliant risk management systems, procedures and practices and is responsible for the Risk Management File portion of the product Design History File.
This position could be located at our facility in Flagstaff, Arizona or Phoenix, Arizona.
Responsibilities
  • Own product line risk management files; partner with product teams to create, manage, and maintain product risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements
  • Support technical investigations and problem-solving efforts to address product or process issues, resolve technical uncertainties, and improve product performance
  • Partner with other engineers in a wide range of process projects throughout the development cycles: scale-up, validation, and improvement (improved safety, cost, quality, capability, and capacity)
  • Partner with new product development teams to ensure appropriateness and adequacy of quality management system documentation, facilitate design and development planning and execution
  • Utilize Risk Management File and Design History File documents to assess risk resulting from design and manufacturing process changes, manufacturing events and post-market surveillance
  • Perform periodic review of Risk Management File documents to ensure the files remain reflective of data/trending signals and ongoing activities
  • Partner with subject matter experts in the development, maintenance and promotion of risk management processes for medical devices, including management and maintenance of global policies and procedures
  • Help to execute divisional changes to Risk Management Files due to changes in standards, regulations, or industry best practices
  • Ensure consistency of Risk Management Files across product line
  • Practice equitable and inclusive behaviors with other Associates to achieve outstanding results

Required Qualifications
  • Bachelor's Degree in Engineering, Science or Technical Field
  • Minimum 5 years' experience with product risk management processes
  • Experience applying structured problem-solving approach (such as 8D, 8-Step, DMAIC or PDCA) that drives root cause analysis using 5-Why, Why Trees, and Fishbone analysis
  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Part 803 and 820, ISO13485, ISO14971, EN 62366-1, and European Medical Device Regulations
  • Knowledge of product risk management (risk identification, analysis, and mitigation methods), medical device product design and manufacturing processes
  • Ability to apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activities
  • Ability to work effectively in team situations, building an inclusive environment, mentoring others as well as the ability to independently prioritize, initiate and drive projects from development to completion within agreed upon timelines.
  • Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making
  • Strong verbal, presentation, and written communication skills
  • Ability to travel up to 10%

Desired Qualifications
  • Product risk management process experience in the medical device/pharmaceutical industry
  • Experience with design controls, risk management, and requirements management within new product development (NPD) environments
  • Strong analytical and organizational skills, flexibility, and attention to detail

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