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Medical Device Risk Management Jobs in Portland, OR

Marmon Holdings, Inc.

Quality Engineer 2

Hillsboro, OR · On-site

$78K - $101K/yr

The QE II serves as the Quality lead during development and manufacturing, using risk management ... Implantable medical device experience preferred. * Knowledge of FDA 21 CFR 820, ISO 13485, ISO ...

US Bank

Credit Risk Analyst

Gresham, OR · Hybrid

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The organization's risk management structure is designed to promote effective governance and risk ... Our benefits include the following: * Healthcare (medical, dental, vision) * Basic term and ...

New

PacifiCorp

Director, Internal Audit and Risk Management

Portland, OR · On-site

$155K - $213K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Minimum of 10 years of experience in audit, risk management, compliance, or related fields, with at ... Medical, dental, and vision insurance * 401k with match fixed contributions, including a Roth and ...

Marmon Holdings, Inc.

Senior Quality Engineer

Hillsboro, OR · On-site

$96K - $130K/yr

Drives product risk management activities. Ensures identified activities and mitigations are ... Medical Device Directive, etc.). * Experience with CAPA and failure investigation tools and ...

Marmon

Senior Quality Engineer

Hillsboro, OR

$96K - $130K/yr

Drives product risk management activities. Ensures identified activities and mitigations are ... Medical Device Directive, etc.). * Experience with CAPA and failure investigation tools and ...

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Showing results 21-40

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Portland, OR

Medical Device Risk Management information

See Portland, OR salary details

$54.6K

$118.3K

$180.3K

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

As of Aug 15, 2026, the average yearly pay for medical device risk management in Portland, OR is $118,306.00, according to ZipRecruiter salary data. Most workers in this role earn between $95,400.00 and $136,800.00 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 Portland, OR look for?

The top searched job categories for Medical Device Risk Management jobs in Portland, OR are:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Portland, OR as of June 2026, with employment types broken down into 1% As Needed, 89% Full Time, 1% Part Time, 1% Temporary, and 8% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $118,306 per year, or $56.9 per hour.

Quality Engineer 2

Marmon Holdings, Inc.

Hillsboro, OR • On-site

$78K - $101K/yr

Full-time

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

Marmon Holdings rating

7.7

Company rating: 7.7 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

Job description

Acumed LLC
As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway-you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.
Job Scope
The NPI Quality Engineer II leads quality planning and ensures the quality of new products from development through market release. This role drives quality objectives during product development, ensuring compliance with FDA, ISO 13485, and other global standards. The QE II serves as the Quality lead during development and manufacturing, using risk management and root cause analysis to identify, assess, resolve, and communicate quality issues with limited supervision.
Responsibilities
  • Represent Quality on new product development teams for design control, verification/validation, design transfer, risk management, and specifications while ensuring compliance with FDA, ISO 13485, and company requirements.
  • Support engineering and manufacturing with verification, validation, and design transfer activities; define validation needs.
  • Train and guide cross-functional teams on quality regulations, procedures, and requirements.
  • Ensure complete, compliant Design History Files and Engineering Change Orders.
  • Provide quality support throughout the product lifecycle, including CAPA, Health Hazard Evaluations, risk management, and design changes.
  • Lead product risk management activities and ensure mitigation actions are completed.
  • Participate in technical discussions and issue resolution using risk-based decision making.
  • Process Non-Conforming Material Reports and disposition nonconforming products for new launches.
  • Develop and maintain final inspection plans; support validation of inspection methods.
  • Coordinate with suppliers on design transfer quality deliverables.
  • Review verification/validation protocols and reports for cGMP compliance and support gap closure.
  • Report progress, escalate issues, support data analysis, and prepare verification/validation reports.
  • Drive continuous improvement by identifying and implementing enhancements to design and development processes.

Qualifications
  • Bachelor's degree in Engineering or Science with 2+ years of quality experience in a regulated environment, or 8+ years of equivalent experience.
  • Implantable medical device experience preferred.
  • Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, MDR/MDD, and related regulations.
  • Experience with CAPA, root cause analysis, Six Sigma, FMEA, DOE, risk analysis, statistical methods, and trend analysis.
  • Strong technical writing, communication, teamwork, and problem-solving skills.
  • Proficient with SAP/ERP, Microsoft Office (advanced Excel), Minitab, and GD&T.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.

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