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Medical Device Risk Management Jobs in Portland, OR

Columbia Banking System

Credit Risk Analyst

Tigard, OR · On-site

$90K - $120K/yr

Work with Model Risk Management to ensure models are validated and remediate any findings.Develop ... We offer eligible associates comprehensive healthcare coverage (medical, dental, and vision plans ...

Jobtailor

Territory Manager

Portland, OR · On-site

Medical Device Sales Experience * Sales Strategy Development * Strong Presentation Skills * Knowledge of Human Anatomy * Customer Relationship Management Hard Skills * Sales Revenue Achievement

New

MRINetwork Jobs

Medical Support Assistant

Vancouver, WA · On-site

$42K - $54K/yr

This role supports patient care operations by coordinating appointments, managing patient ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...

MRINetwork Jobs

Medical Support Assistant

Vancouver, WA · On-site

$42K - $54K/yr

This role supports patient care operations by coordinating appointments, managing patient ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...

MRINetwork Jobs

Medical Support Assistant

Vancouver, WA · On-site

$42K - $54K/yr

This role supports patient care operations by coordinating appointments, managing patient ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...

MRINetwork Jobs

Medical Support Assistant

Vancouver, WA · On-site

$42K - $54K/yr

This role supports patient care operations by coordinating appointments, managing patient ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...

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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 Sep 10, 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 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 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.

Medical Systems Engineer - Mechanical

Lake Oswego, OR • On-site

BIOTRONIK SE & Co.KG
See more jobs at BIOTRONIK SE & Co.KGexternal

Other

Posted 7 days ago

Job description

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company’s corevalues - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling usto inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

Please join us as:

Medical Systems Engineer - Mechanical

Systems Engineer - Mechanical Engineer to join our R&D team. This role places you at the technical center of development of complex implantable medical devices focusing on the design of mechanical aspects of active implantable devices and their accessories. The role involves collaboration across multidisciplinary teams including mechanical, electrical and software teams. This role involves contributions from prototype phases through verification and validation, all the way to post-market product support.

Key Responsibilities

System Design & Integration

  • Lead mechanical design and system integration of implantable and accessory devices.
  • Define and manage subsystem requirements and interfaces.
  • Collaborate with electrical, manufacturing and human factors engineering teams to ensure cohesive system design.

Prototyping & Development

  • Support rapid prototyping, including 3D printing and bench testing.
  • Apply iterative development methods to refine mechanical components.
  • Verification, Validation & Testing
  • Develop and execute test plans to ensure compliance with performance, safety, and regulatory requirements.
  • Support and lead risk management activities, including FMEA, fault tree analysis, and root cause investigations.
  • Regulatory & Standards Compliance
  • Ensure design activities comply with relevant standards (e.g., IEC 60601, ISO 14971, FDA QSR, EU MDR).
  • Document system behavior and design decisions in line with regulatory expectations.

Post-Market Engineering

  • Provide technical support for released products, including root cause analysis and implementation of design improvements.
  • Analyze field and product performance data to drive continuous improvement.

Your Profile

Education

  • Bachelor's Degree or higher in a technical field such as Mechanical Engineering, Biomedical Engineering, or a related discipline.
  • Work Experience
  • Industry Experience: Minimum 5 years of experience in mechanical or systems engineering and preferably:
    • Experience with neurostimulation or other similar active implantable devices.
    • Exposure to manufacturing processes for implantable devices.
    • Understanding of human factors and usability engineering in medical systems.

Desired Technical Skills & Competencies:

  • Proficient in mechanical design and CAD (Solidworks or similar)
  • Experience with mechanical prototyping and 3D printing.
  • Knowledge of verification and validation practices (Design & Process V&V).
  • Understanding of biocompatibility testing and materials for implantable
  • Proficiency in at least one data processing, scripting and plotting software (e.g. VS Code, Matlab, python)
  • Experience writing technical documents and working drawings for manufacturing
  • Experience working with regulatory standards such as ISO 14708, IEC 60601, FDA 21 CFR 820.11, MDR and ISO 14971.
  • Experience working in requirements management tools
  • Project Management Skills: Proven ability to organize, prioritize, and execute multiple projects in a fast-paced, detail-oriented environment.
  • Communication & Teamwork: Strong interpersonal and communication skills, with the ability to effectively collaborate across teams and present complex ideas clearly.
  • Ability to prioritize effectively and work on concurrent projects.
  • Excellent problem-solving and analytical skills.
  • Strong communication and interpersonal skills including technical report writing skills.

Location

  • Lake Oswego, OR this is a hybrid position.

Working hours: Full-time

Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee

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