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Medical Device Risk Management Jobs in Portland, OR

Stryker

Senior Staff Medical Writer (Remote)

Portland, OR · On-site +1

$143K - $238K/yr

Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745 ... Knowledge of clinical operations, risk management, and international regulatory requirements.

Kaiser Permanente

ENGR, MED IM III

Clackamas, OR · On-site

Under the general supervision of the Clinical Technology Manager and Chief Medical Imaging Engineer, performs duties pertaining to acquisition, installation, calibration, repair and maintenance of ...

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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 9, 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.

Technical Program Manager - AI Medical Devices

Portland, OR • On-site

Prenuvo
Health Care and Social Assistance • 51 - 200 employees
Learn more about Prenuvoexternal

$136K - $177K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 12 days ago

Key responsibilities

  • Coordinate the end-to-end execution of AI-enabled medical-device programs, including planning, scheduling, and progress tracking.

  • Collaborate with cross-functional teams such as AI/ML engineers, systems engineers, regulatory affairs, product, and clinical operations to synchronize deliverables.

  • Manage project documentation, track milestones, and support regulatory readiness and design control activities.

Job description

About Us

At Prenuvo, we are on a mission to flip the paradigm from reactive "sick-care" to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against "we caught it too late again".

We are hiring a Technical Program Manager, AI Medical Devices to coordinate the end-to-end execution of Prenuvo's AI-enabled medical-device programs.

You will work across AI Research, Engineering, Systems Engineering, Product, Quality, Regulatory, Clinical, and other teams to turn technically complex medical-device initiatives into clear, executable programs.

You will connect product development, model development, systems engineering, validation, quality, regulatory readiness, launch, change management, and post-market activities into one integrated plan.

By making this work more structured and scalable, you will help Prenuvo's AI and device teams increase their capacity to develop and evolve our product portfolio.

This role does not provide visa sponsorship. Applicants must be legally authorized to work in Canada or the USA at the time of hire and must not require employer sponsorship for a work visa (current or future).

Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people's lives!

What You'll Do

  • Program Coordination: Support project planning, scheduling and progress tracking for multiple AI device programs.
  • Cross-Functional Alignment: Collaborate closely with AI/ML engineers, systems engineers, regulatory affairs, product teams and clinical operations to keep deliverables synchronized across teams.
  • Documentation Management: Set up and maintain project documentation in Jira and other tools, track milestones and ensure all design control and regulatory deliverables are up to date.
  • Quality and Compliance: Support readiness for regulatory submissions (such as 510(k), IDE, Health Canada) and plan/execute design control design reviews, including capturing clear summaries and follow-ups.
  • Reporting and Communication: Facilitate reporting and communicate project status, risks, and dependencies to the program team and stakeholders.
  • Continuous Improvement: Identify process gaps and contribute ideas to improve collaboration, documentation flow and delivery efficiency.

What You'll Bring

  • 5+ years of experience in Technical Program Management, Technical Project Management, Engineering Program Management, medical-device product development, or a closely related discipline.
  • 2+ years working with regulated medical devices, Software as a Medical Device, digital health, or similarly regulated clinical technology.
  • Experience coordinating multidisciplinary technical programs from development through verification/validation and launch.
  • Strong technical fluency and the ability to work credibly with software engineers, systems engineers, AI/ML researchers, and technical product leaders.
  • Familiarity with machine-learning development concepts such as datasets, model performance, validation, inference, deployment, and production monitoring. You do not need to be an ML engineer.
  • Working knowledge of regulated medical-device development practices, including design controls, risk management, verification and validation, change control, and post-market processes.
  • Experience working with Quality and Regulatory teams on FDA and/or Health Canada regulated products.

Nice to Haves

  • Familiarity with standards such as ISO 13485, ISO 14971, and IEC 62304 is strongly preferred.
  • Experience specifically with AI/ML-enabled medical devices or SaMD is strongly preferred.
  • Experience coordinating clinical validation or clinical-performance evaluation is a plus.
  • Excellent program-planning, dependency-management, and risk-management skills.
  • Exceptional communication and the ability to create clarity across specialized technical disciplines.
  • Comfort operating in a fast-moving environment where the processes required to scale are still being built.

Our Values 

First: we are Pioneers

  • Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.

Second: we are Platform-Builders

  • We're always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what's ahead – in a mindset of ownership and duty to our mission.

Above all: we are Patients

  • We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients' lives, and we won't stop till everyone can benefit from our work.

What We Offer

  • An avenue to make a positive impact on people's lives and their health
  • We believe in preventative healthcare for everyone, including our team - Prenuvo provides free, whole-body scans to each team member 
  • Growth opportunities are at the heart of our people journey, we're doing big things with bright minds - there is no single path to success, it can be shaped along the way
  • Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize 
  • Recognizing time away to restore is vital to our wellbeing - we have a flexible vacation policy and we will encourage you to use it
  • We now offer the Prenuvo's Commuter Benefits Plan to help cover your transit and parking costs. Whether you ride, drive, or park, we've got you covered—making your commute easier and more affordable! 
  • Prenuvo offers a 401(k) retirement savings plan to eligible employees, allowing team members to make pre-tax contributions toward their retirement. While Prenuvo facilitates access to the plan, the company does not currently offer matching contributions.
  • We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, to support you and your family.
  • The base salary for this role ranges from $170,000-$200,000 in local currency, depending upon experience and geographic location

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules.

Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends with @prenuvo.com. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to jobs@prenuvo.com.