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Medical Device Risk Management Jobs in Boston, MA

SharkNinja

Senior Medical Device Compliance Engineer

Needham, MA · On-site

$113K - $156K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Ensure risk management activities including hazard analysis, DFMEA, and test planning in alignment ... with medical device requirements. * Support internal audits, supplier audits, and regulatory ...

Butterfly Network

Staff Design Quality Engineer

Burlington, MA · On-site +1

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Experience owning or maintaining medical device risk management files in accordance with ISO 14971. * Excellent proficiency with 8D problem-solving tools and methods, including root cause analysis ...

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · Hybrid

$138K - $185K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical ...

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · On-site

$138K - $185K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical ...

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Showing results 1-20

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Boston, MA

Medical Device Risk Management information

See Boston, MA salary details

$56K

$121.2K

$184.7K

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 Boston, MA is $121,195.00, according to ZipRecruiter salary data. Most workers in this role earn between $97,800.00 and $140,100.00 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 Boston, MA?

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

What job categories do people searching Medical Device Risk Management jobs in Boston, MA look for?

The top searched job categories for Medical Device Risk Management jobs in Boston, MA are:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Boston, MA as of August 2026, with employment types broken down into 100% Contract. Highlights an 67% In-person, and 33% Remote job distribution, with an average salary of $121,195 per year, or $58.3 per hour.

Medical Device Risk Management Advisor (Part-Time, Remote)

FocusKPI Inc.

Boston, MA • Remote

Contractor

Re-posted 28 days ago

Job description

We are building an AI-powered platform to support medical device risk management and regulatory documentation (including ISO 14971 and design controls), and are looking for a few professionals to serve as ongoing product feedback advisors.

This is a flexible, part-time opportunity for experienced professionals who can periodically test new features, review workflows, and provide practical feedback based on real-world medical device and regulatory experience. Your input will directly shape how the product supports day-to-day work in regulated environments.

What You’ll Do
  • Test new features and prototypes periodically
  • Provide feedback on usability and regulatory alignment
  • Review risk management and documentation workflows
  • Suggest improvements based on real industry practice
  • Join occasional 30–45 minute feedback sessions
Time Commitment
  • Flexible, ongoing engagement
  • Approximately 1–2 hours per week or biweekly
  • Fully remote
Preferred Background
  • Medical device regulatory affairs or quality assurance
  • Experience with ISO 14971 risk management
  • Design controls / DHF documentation
  • 510(k), De Novo, or PMA experience is a plus
  • Risk management file, FMEA, or hazard analysis experience

Consultants and industry professionals are welcome.

How to Apply

If you’re interested, please complete this short screening form so we can better understand your background:
https://forms.gle/jgj1ZN2jtAGGAbYQA

We’ll follow up with selected candidates to schedule an initial session and discuss next steps.

NOTICE: Please be aware of fraudulent emails regarding job postings, job offers and fake checks. FocusKPI's recruiting team will strictly reach out via @focuskpi.com email domain. If you have received fraudulent emails now or in the past, please report it to https://reportfraud.ftc.gov/ .
The domain @focuskpijobs.com is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @focuskpijobs.com.

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FocusKPI logo

About FocusKPI

Sourced by ZipRecruiter

Industry

Computing infrastructure providers, data processing, web hosting

Company size

51 - 200 Employees

Headquarters location

Santa Clara, CA, US

Year founded

2010

View All FocusKPI Jobs