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Medical Device Risk Management Jobs in Ashburn, VA

MedStar Health

Director Risk Management

Washington, DC · On-site

Works closely with the AVP of Medical Professional Liability in the system Risk Management ... Department in assessing and evaluating active claims for MGUH. * Initiates and participates in the ...

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Medical Device Risk Management information

See Ashburn, VA salary details

$52.7K

$114.1K

$173.8K

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 Ashburn, VA is $114,078.00, according to ZipRecruiter salary data. Most workers in this role earn between $92,000.00 and $131,900.00 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 Ashburn, VA look for?

The top searched job categories for Medical Device Risk Management jobs in Ashburn, VA are:

What cities near Ashburn, VA are hiring for Medical Device Risk Management jobs?

Cities near Ashburn, VA 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 Ashburn, VA as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 18% Part Time, and 5% Contract. Highlights an 88% Physical, 1% Hybrid, and 11% Remote job distribution, with an average salary of $114,078 per year, or $54.8 per hour.

Medical Device Engineer or Materials Scientist (Implantable Device Degradation)

Bethesda, MD • On-site

Tunnell Government Services
See more jobs at Tunnell Government Servicesexternal

Full-time

Posted 29 days ago

Job description

Medical Device Engineer or Materials Scientist (Implantable Device Degradation) SME Position Description - 12 Month Term Position 

The successful candidate will be either an Engineer (Biomedical, Chemical, Mechanical) or Materials Scientist and Medical Device subject matter expert, with extensive experience involving degradation (fretting, wear, and corrosion) of implantable medical devices.

They will provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices, with specific attention to premarket submissions that include mechanical functions. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc.

The candidate should possess expertise and/or direct experience enabling the competent analysis of key components of the regulatory approach to assess device risk to a patient, a user of a device, or others in the environment of use. These include, but are not limited to analysis of aspects such as device design and modeling, analysis and simulation, material selection, prototyping and testing, manufacturing, documentation, and human factors/ergonomics.

The candidate should be familiar with applicable industry standards and regulatory requirements, such as, but not limited to, FDA Guidances (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices), US regulatory standards (21 CFR Part 820 -- Quality System Regulation), and ANSI standards (ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices).

The candidate should also possess expertise, and/or direct experience enabling them to act as a subject matter expert on matters pertaining to medical device basic safety and essential performance.  The candidate should also have experience involving the design and analysis of medical device systems, and performance of, and interpretation of results produced through standardized device testing approaches, in support of regulatory approval. The candidate should have appropriate training and experience necessary to provide effective consulting support in medical devices areas such as but not limited to shear stress evaluation, flow optimization, and standardized safety testing (i.e. ISO 10993-4). The candidate's experience should include knowledge of applicable standards, testing procedures, testing equipment, verification and validation of methods, preparation of test plans, reporting of results. 

Qualifications

  • The candidate must possess an advanced degree (MS, PhD) in in the field of Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or equivalent.
  • The candidate must possess specific, demonstrable expertise and experience involving degradation (fretting, wear, corrosion) of implantable medical devices, preferably orthopedic and cardiovascular implants. Prior work experience and/or publications in peer-reviewed sources is necessary to demonstrate qualifications. 
  • The candidate must have experience with mechanical and chemical performance testing of orthopedic and cardiovascular medical device implants.
  • 10 years of experience is required (direct experience in medical device engineering and/or materials science)
  • General knowledge and experience with a variety of medical device development technical disciplines
  • Experience with directly supporting FDA 510(k) and related regulatory submissions
  • Exceptionally strong written and verbal communication skills
  • Ability to communicate well with others using excellent written and verbal communication skills.
  • Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
  • Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Responsibilities

  • The primary focus of the role is to support analyses of medical device degradation relative to regulatory and technical aspects of mechanical/chemical engineering or materials science.
  • Provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and De Novo marketing applications, Pre-submissions)
  • Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders
  • Develop written reviews and correspondence
  • Write detailed documents and reports

Job Type:  Full Time Employee

Schedule:  Monday through Friday (No Holidays)

Location:  This position is 100% telework. 

Must be US Citizen or full Green Card holder.

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