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Medical Device Risk Management Jobs in Oregon (NOW HIRING)

HealthEquity

Sr Third Party Risk Analyst (TPRM)

$87K - $111K/yr

NIST AI Risk Management Framework (AI RMF) * ISO 42001 * Prior experience with TPRM / GRC platforms ... Medical, dental, and vision * HSA contribution and match * Dependent care FSA match * Uncapped paid ...

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 ...

Fujifilm

Legal Compliance Manager (Corporate)

Identify potential areas of compliance vulnerability and risk. Develop and implement action plans to mitigate potential risks. * Develop and manage compliance training on the Fujifilm Medical Device ...

BECU

Sr Credit Risk Analyst

OR · On-site +1

$82K - $154K/yr

Medical, Dental and Vision (family contributions as well) * PTO Program + Exchange Program ... Manage projects and analytical initiatives from data discovery through recommendations while ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Oregon

Medical Device Risk Management information

See Oregon salary details

$54.5K

$117.9K

$179.7K

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 Oregon is $117,947.00, according to ZipRecruiter salary data. Most workers in this role earn between $95,200.00 and $136,400.00 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 are popular job titles related to Medical Device Risk Management jobs in Oregon?

For Medical Device Risk Management jobs in Oregon, the most frequently searched job titles are:

What job categories do people searching Medical Device Risk Management jobs in Oregon look for?

The top searched job categories for Medical Device Risk Management jobs in Oregon are:

What cities in Oregon are hiring for Medical Device Risk Management jobs?

Cities in Oregon with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Oregon as of June 2026, with employment types broken down into 98% Full Time, and 2% Part Time. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $117,947 per year, or $56.7 per hour.

Sr. Clinical Trial Manager (Cardiac Catheter Products)

Pulse Biosciences

OR • On-site, Remote

Full-time

Re-posted 9 days ago

Job description

About the Role

The Sr. Clinical Trial Manager is primarily responsible for working closely with cross functional teams, vendors, sites and CROs to ensure compliance with global clinical trials for the 360 AF catheter ablation system. S/he is responsible for completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives.

To Make an Impact, You Will:

  • Lead feasibility assessments, site selection, and activation for cardiology centers capable of handling complex AF trial requirements
  • Proactively create and execute patient recruitment strategies and risk mitigation plans to meet study milestones.
  • Supervise Contract Research Organizations (CROs), core labs (e.g., ECG/Holter monitoring), and external vendors to ensure deliverables are met on time and within scope.
  • Assist in regulatory submissions to (CA, IRB/ECs) according to local requirements or e-submission through the Common European Submission Portal (CESP) in coordination with or without CRO.
  • Proactively track and manage project tasks against timelines by creating a Smartsheet or timely minutes to alert management when there are risks of having major deviations.
  • Draft and coordinate review of relevant documents including informed consents, source documents for data entry, power-point slide deck for site initiation visit, monitoring plans, clinical study and/or safety reports and study materials (e.g., newsletters, recruitment posters, study logs, etc.).
  • May assist in the preparation of documents required by Clinical Study Readiness.
  • May perform review and Quality Control (QC) study documents filed in the study Trial Master File (eTMF) and Investigator Site File (eISF) as needed.
  • Oversee device tracking/accountability and reconciliation procedures at participating centers.
  • May conduct and/or attend SQVs, SIVs, IMVs and COVs and conduct site-level training, as needed.
  • Advise on site data collection and attend 360 AF catheter ablation clinical procedures as needed.
  • May perform User Acceptance Testing (UAT) in database for initial and ongoing eCRF development and contribute to the review of EDC guidelines.
  • Oversee the clinical aspects of timely data cleaning and data analysis by regular review of data metrics and listings.
  • Ensure that device or procedure related adverse events are identified and appropriate responses to such concerns are developed and executed as outlined in Safety Plan and/or Study Protocol.
  • Must have general functional expertise to support SOP development and implementation.
  • Evaluate vendor invoices for completeness and accuracy.
  • Hire, manage and develop internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company's strategic priorities.

To Excel, You Will Bring: 

  • BS/BA (science or healthcare field) or equivalent experience in life sciences required.
  • 7+ years of clinical research with medical device experience including onsite monitoring and oversight of CRAs with a medical device company or medical device CRO.
  • Cardiac electrophysiology clinical trial experience is a plus.
  • Cardiac device experience with an early start up company is a plus.
  • Current ICH GCP certification is strongly preferred.
  • Thorough knowledge of FDA and EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical trials involving class II/III devices.
  • In-depth understanding of Atrial Fibrillation pathophysiology, standard-of-care treatments (ablation, cardioversion, antiarrhythmics), and complex trial designs
  • Demonstrated ability to drive project related activities.
  • Proficient knowledge and skill in Acrobat Adobe, Smartsheet and Microsoft Office Suite applications with the ability to quickly become proficient in a variety of other computer software programs.
  • Proficient in clinical trial management systems including electronic data capture (EDC) software (Medidata and others), and other platform related to electronic Trial Master File (eTMF).
  • Excellent communication, written and organizational skills (ability to prioritize a number of tasks of varying complexity).
  • Ability to analyze and interpret clinical data.
  • Must recognize and commit to a sense of urgency and teamwork.
  • Strong ability in problem-solving including conflict resolution.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work in a fast-paced environment with multiple competing tasks and demands, across time-zones.
  • Ability to travel up to 40% of the time (domestic).
  • Ability to lift 10-15 pounds.

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