ZipRecruiter

Log In

1

Medical Device Risk Management Jobs in Boston, MA

SharkNinja

Compliance Engineer

Needham, MA

... Risk Management for Medical Devices ISO 13485 - Quality Management Systems IEC 62366-1 - Usability Engineering IEC 62304 - Medical Device Software Lifecycle (where applicable) ISO 10993 series ...

Old Colony YMCA

Sr. Director Risk Management

Brockton, MA · On-site

... device. The employee frequently is required to sit and reach, and must be able to move around the ... Knowledge of enterprise risk management and safety techniques programs, loss control practices, and ...

Rockland Trust

IT Risk Analyst

Plymouth, MA

With a broad range of banking, wealth management, and investment solutions, Rockland Trust combines ... Conduct application and device risk assessments to gather risk specific information about ...

Rockland Trust

IT Risk Analyst

Plymouth, MA

With a broad range of banking, wealth management, and investment solutions, Rockland Trust combines ... Conduct application and device risk assessments to gather risk specific information about ...

ConsignMed Inc.

Be Seen First

PRN Medical Device Rep/Clinical Specialist (Boston/Northeast)

Boston, MA · On-site

$50 - $250/hr

... management services available as an independent/voluntary resource Company Description We are a niche CRO specializing in building field support teams for the medical device & pharma space. We match ...

New

LivaNova

Manager, Enterprise Risk Management

Boston, MA

$110K - $150K/yr

... Enterprise Risk Management is responsible for overseeing and coordinating the organization ... Health benefits - Medical, Dental, Vision * Personal and Vacation Time * Retirement & Savings Plan ...

next page

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 Jun 13, 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:
What cities near Boston, MA are hiring for Medical Device Risk Management jobs? Cities near Boston, MA 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 Boston, MA as of June 2026, with employment types broken down into 1% As Needed, 87% Full Time, 4% Part Time, and 8% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $121,195 per year, or $58.3 per hour.
Compliance Engineer

Compliance Engineer

SharkNinja

Needham, MA

Other

Posted 4 days ago

Job description

The Product Compliance Engineer will partner with global product developers and certification partners on regulatory compliance and product certification. The candidate will support certification projects from product concept to mass production, ensuring market access requirements are met and that product designs incorporate appropriate risk mitigation solutions. This role includes participation in medical device regulatory pathways alongside our consumer and commercial product portfolio.

Here are some of the EXCITING things you'll get to do:

Support the execution of certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745.

Assist in preparing regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485 requirements.

Support the establishment of project needs and deliverables for both product development teams and third-party regulatory partners, including Notified Bodies and FDA-accredited testing laboratories.

Execute risk management activities in accordance with ISO 14971, including hazard identification, risk estimation, risk evaluation, and residual risk documentation across the product lifecycle.

Support usability engineering processes per IEC 62366-1, including participation in formative and summative evaluation planning for medical device products intended for home healthcare environments.

Evaluate project risk during the development process and support contingency planning to overcome obstacles, including regulatory strategy adjustments driven by classification questions or design changes.

Participate in weekly reviews for all assigned projects, presenting status and associated project risks including certification timelines and Notified Body or FDA feedback cycles.

Assure that all activities related to product certification commence and execute as planned and on schedule, with attention to FDA review timelines and CE marking milestones under EU MDR.

Support product development teams as a subject matter expert, providing counsel on medical device-specific requirements including biocompatibility (ISO 10993 series), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601-1-11).

Contribute to intradepartmental continuous improvement and special projects, including post-market surveillance and complaint handling processes under 21 CFR Part 803 and EU MDR.

Attributes & Skills

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline; RAC certification a plus.

Relevant discipline context: Biomedical/Bioengineering backgrounds are well-suited to ISO 10993 biocompatibility and clinical evaluation; Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials Engineering to material selection, substance compliance (REACH, RoHS), and biocompatibility testing; Computer Science/Software Engineering to IEC 62304 software lifecycle and embedded systems compliance.

Minimum 2-4 years of compliance or design-related experience with consumer, commercial, or medical electromechanical products.

Working knowledge of medical device regulatory standards including:

IEC 60601-1 and applicable collateral/particular standards (esp. IEC 60601-1-2 for EMC, IEC 60601-1-6 for usability, IEC 60601-1-11 for home healthcare environments)

ISO 14971 - Risk Management for Medical Devices

ISO 13485 - Quality Management Systems

IEC 62366-1 - Usability Engineering

IEC 62304 - Medical Device Software Lifecycle (where applicable)

ISO 10993 series - Biocompatibility Evaluation

21 CFR Part 820 - FDA Quality System Regulation

EU MDR 2017/745 - classification rules, Technical Documentation, and UDI obligations

FDA 510(k) submission processes

Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil) preferred.

Experience with DFMEA and medical-grade risk management documentation (hazard analysis, risk control verification, residual risk justification).

Exposure to or experience interfacing with FDA, Notified Bodies, or accredited test laboratories preferred.

Must be able to:

Operate comfortably in a fast-paced environment with regularly shifting priorities, including simultaneous consumer and regulated-device program timelines.

Thrive under pressure and want to be continuously challenged.

Manage multiple projects simultaneously while maintaining continuous track of key details, including regulatory submission status and design change impact assessments.

Multi-task, maintaining a comprehensive understanding of project status across consumer certification and medical device regulatory workstreams.

Present creative and technically sound solutions to complex problems, including regulatory pathway questions where classification is ambiguous.

Like to "solve the puzzles" and deliver on challenging assignments.

Analyze operations and support continuous improvement initiatives within a design control and post-market surveillance framework.

Work with conviction while collaborating and compromising where appropriate.

Work and think with moderate supervision and generate ideas within their area of expertise.

Make sound decisions utilizing all available information, including benefit-risk trade-offs required under ISO 14971.

Communicate complex technical and regulatory information to audiences with varying technical understanding.

Adapt well to change, including evolving regulatory guidance and new product category entries into regulated spaces.

Present confidently to colleagues and leadership across the organization.

Desire ownership and possess a "want to take the last shot of the game" mentality.

Apply