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Medical Device Risk Management Jobs in Portland, OR

Clinical Risk Manager Sr

Vancouver, WA

$105K - $158K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... with senior management on appropriate responses to risk events and medical care complaints in ... Device Reporting, Adoptions and other topics. * Assists Patient Relations to address complex ...

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Cybersecurity Risk Analyst (REMOTE)

Portland, OR · Remote

$90K - $100K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... medical devices and Special Purpose Systems (e.g., building automation systems, physical security ... The analyst works within a Risk Management team and is expected to collaborate with Federal and ...

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 ...

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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:

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.

Clinical Risk Manager Sr

PeaceHealth

Vancouver, WA

$105K - $158K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 26 days ago


PeaceHealth rating

7.7

Company rating: 7.7 out of 10

Based on 175 frontline employees who took The Breakroom Quiz

157th of 887 rated healthcare providers


Job description

Description

PeaceHealth is seeking a Clinical Risk Manager Sr for a Full Time, 1.00 FTE, Day position. The salary range for this job opening at PeaceHealth is $105,851– $158,766. The hiring rate is dependent upon several factors, including but not limited to education, training, work experience, terms of any applicable collective bargaining agreement, seniority, etc.

Job Summary

The Senior Clinical Risk Manager leads the investigation and management of complex, high-severity risk events across the healthcare system. Provides strategic leadership and oversight in the identification, evaluation, and mitigation of clinical risks for their assigned areas. This role provides expert-level consultation on clinical risk, supports regulatory compliance, and leading enterprise-wide initiatives to enhance patient safety and reduce liability. In addition, this role is responsible for mentoring and supporting our clinical risk managers. The Senior Clinical Risk Manager collaborates with executive leadership, legal counsel, and clinical teams to drive a proactive risk management culture and ensure compliance with regulatory standards.

Essential Functions

  • Leads the identification and investigation of high-severity risk events, including coordination with legal, patient safety, compliance, and executive leadership. Collaborates with legal counsel on complex claims and litigation support.
  • Oversees and guides Root Cause Analyses (RCAs), Failure Mode and Effects Analyses (FMEAs), Apparent Cause Analysis, and other risk assessments. Leads proactive risk assessments for high-risk areas.
  • Serves as a senior advisor to clinical and operational leaders on risk mitigation strategies and patient safety initiatives. Develops and communicates with senior management on appropriate responses to risk events and medical care complaints in accordance with legal requirements.
  • Develops and implements system-wide risk management standard work, protocols, and policies. Leads the development and delivery of advanced risk management education and training. Provides mentorship, training, and support for clinical risk managers.
  • Analyzes system-wide trends in incident reporting, tracks key performance indicators, and develops strategic recommendations for improvement. Regularly provides leadership with progress reports and data (including recommendations) related to risk management. Provides leadership of performance improvement and loss prevention activities.
  • Represents the Risk Management department on committees and task forces focusing on high-risk issues.
  • Investigates alleged EMTALA violations. Ensures that applicable regulatory and accreditation requirements are met in a proactive manner. Participates in development of processes/systems designed to share and recognize performance improvements and compliance across the organization to mitigate risks to patient and caregiver safety/risks to the organization.
  • Facilitates teams related to system-wide approaches for risk mitigation. Supports skills and competency development in risk management for community-based resources. With system team, designs training curriculum, develop program content and provide education to leadership teams, quality leaders, supervisor other caregivers/providers.
  • Serves as system subject matter expert for risk mitigation strategies on high-risk topics such as OB, ED, ICU and Behavioral Health service lines or Informed Consent, Use of Force oversight, Laser Safety, Medical Device Reporting, Adoptions and other topics.
  • Assists Patient Relations to address complex grievances that involve patient care and responds to the patient in the time frame designated by policy.
  • In partnership with the Quality department, leads the organization’s regulatory response in the event of a formal patient complaint or EMTALA survey and corrective action plan.
  • Serves as the lead for the communication & resolution program (disclosure process) in assigned areas of responsibility.
  • Monitors and interprets changes in healthcare regulations and proactively adjusts risk strategies to maintain compliance.
  • Serves as the non-discrimination officer for their assigned areas of responsibility.
  • Performs other duties as assigned.

Qualifications

Education

  • Bachelor's Degree Required: in Nursing or other clinical field and
  • Master's Degree Preferred: in nursing, healthcare administration, public health or related field

Experience

  • Minimum of 5 years Required: Healthcare risk management, compliance, quality improvement or patient safety or
  • Minimum of 5 years Required: Combination of directly related clinical experience AND risk management, compliance, quality improvement, or patient safety

Credentials

  • Required: RN, or license clinical discipline (RN preferred) in OR, WA, or AK and
  • Required: within 2 years Certified Professional Healthcare Risk Management

Skills

  • Advanced knowledge of state, federal, and accreditation requirements including but not limited to: CMS Conditions of Participation for acute care and critical access hospitals. (Required)
  • General knowledge in other regulatory areas such as, OSHA, EMTALA, and HIPPA. (Required)
  • State healthcare rules and statutes, and state licensing requirements. (Required)
  • Proficient with MS Office applications. (Required)
  • Excellent communication, interpersonal, collaboration, and presentation skills. (Required)
  • Advanced analytical and problem-solving skills. (Required)
  • Ability to lead and motivate teams, influence others, and drive change. (Required)
  • Able to work flexible hours. (Required)
  • Participation in on-call coverage. (Required)

Working Conditions

Lifting

  • Consistently operates computer and other office equipment.
  • Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
  • Sedentary work.

Environmental Conditions

  • Predominantly operates in an office environment.
  • Some time spent on site in medical/hospital setting.

Mental/Visual

  • Ability to communicate and exchange accurate information.
  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

PeaceHealth is committed to the overall wellbeing of our caregivers: physical, emotional, financial, social, and spiritual. We offer caregivers a competitive and comprehensive total rewards package. Some of the many benefits included in this package are full medical/dental/vision coverage; 403b retirement plan employer base and matching contributions; paid time off; employer-paid life and disability insurance with additional buyup coverage options; tuition and continuing education reimbursement; wellness benefits, and expanded EAP and mental health program.

See how PeaceHealth is committed to Inclusivity, Respect for Diversity and Cultural Humility.

For full consideration of your skills and abilities, please attach a current resume with your application. EEO Affirmative Action Employer/Vets/Disabled in accordance with applicable local, state or federal laws.


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About PeaceHealth

Sourced by ZipRecruiter

PeaceHealth, based in Vancouver, WA, is a not-for-profit Catholic health system employing approximately 16,000 caregivers, a multi-specialty medical group practice with more than 1,200 providers and 10 medical centers serving both urban and rural communities in Washington, Oregon, Alaska. In 1890, the Sisters of St. Joseph of Peace founded what has become PeaceHealth. Today, the legacy of its founding Sisters continues with a spirit of respect, stewardship, collaboration and social justice in fulfilling its Mission. Get a feeling for the Spirit of PeaceHealth through this three-minute video, and visit us on Facebook or LinkedIn! We offer competitive compensation, a robust benefitspackage and a collaborative, Mission-driven work environment! To learn more please visit: jobs.peacehealth.org. Questions? Review our Employment FAQor email Recruitment@peacehealth.org. Please note this email does not accept resumes or applications.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Vancouver, WA, US

Year founded

1890

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