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Medical Device Risk Management Jobs in Boston, MA

GSK

Associate Director, Device Lead

Waltham, MA · On-site

Lead risk management process as 'risk owner' when required. Why you? Basic qualifications ... DHF, MDR, FDA Medical Device guidance. Preferred Qualifications: * Knowledge of pharmaceutical ...

BEPC INC

Be Seen First

Medical Device Assembler

Westford, MA · On-site

$19 - $21.50/hr

Medical Device Assembler Location : Westford, MA Employment Type : Full-Time| 6 Month contract | W2 ... Follow applicable Quality Management System (QMS), Environmental Management System (EMS), safety ...

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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 Sep 9, 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 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 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 September 2026, with employment types broken down into 87% Full Time, and 13% Contract. Highlights an 87% In-person, and 13% Remote job distribution, with an average salary of $121,195 per year, or $58.3 per hour.

Senior Medical Device Compliance Engineer

Needham, MA • On-site

SharkNinja
Electrical Equipment, Appliance, and Component Manufacturing • 1 - 5K employees
Learn more about SharkNinjaexternal

Full-time

Re-posted 3 days ago

SharkNinja rating

8.2

Company rating: 8.2 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

47th of 162 rated electronics manufacturers

Job description

Senior Medical Device Compliance Engineer 

Needham, MA, United States 

The Senior Medical Device Compliance Engineer is responsible for medical device design control, and post-market compliance across SharkNinja's Medical Devices portfolio. This role is hands-on and central to ensuring medical device products are developed and sustained in compliance with global regulatory requirements-while operating within a fast-paced, consumer electronics development environment. 

In this role, you will hold yourself and cross-functional teams accountable for delivering best-in-class, safe, and effective medical devices that meet customer, business, and regulatory requirements. You will apply best practices and pragmatic, creative problem-solving to support high-speed product development, working closely with Engineering, Product Development, Legal, Program Management, and Quality Engineering, including overseas manufacturing partners. 

Key Responsibilities 

  • Drive design control execution for multiple concurrent medical device NPD programs, ensuring high-quality, audit-ready technical documentation. 
  • Lead and support the creation, review, and approval of Design History Files (DHFs), including design and development plans, requirements, design reviews, risk management files, verification and validation plans and reports, and traceability, ensuring documentation is complete and submission ready. 
  • Translate medical device compliance and regulatory requirements into clear, actionable product and engineering requirements  
  • Ensure risk management activities including hazard analysis, DFMEA, and test planning in alignment with QMS processes. 
  • Support post-market design changes by driving and reviewing ECNs, root cause analysis, risk reassessment, and associated verification/validation and documentation updates. 
  • Serve as a hands-on QMS Compliance leader within cross-functional teams, influencing execution through expertise, collaboration, and clear decision-making in a matrixed environment. 
  • Review supplier qualifications, process validations, and manufacturing documentation from OEMs to ensure compliance with medical device requirements. 
  • Support internal audits, supplier audits, and regulatory inspections  

Qualifications & Experience 

  • Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or a related technical discipline. 
  • 5+ years of experience in design controls, and post-market sustaining of medical devices  
  • Strong experience supporting electromechanical medical devices, preferably within consumer electronics or high-velocity product development environments. 
  • Deep expertise in design controls and risk management, including ISO 14971, hazard analysis, DFMEA, requirements management, and verification/validation. 
  • Experience supporting post-market design changes, including ECNs, root cause analysis, and lifecycle risk management. 
  • Experience working with overseas contract manufacturers and distributors, including qualification, process validation review, and ongoing compliance oversight. 
  • Working knowledge of biocompatibility, electrical safety, labeling, and component change impact assessments. 
  • Strong communication skills and the ability to operate effectively in a complex, matrixed organization. 
  • Pragmatic, detail-oriented mindset suited to fast-paced, innovative-driven environments. 

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