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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 ...

Mondo

Senior Software Design Quality Engineer

Danvers, MA · On-site

$110K - $160K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Work experience with Class III medical device capital equipment development * Experience with owning, conducting and maintaining risk management activities, including the risk management file.

Doist

Territory Sales Manager Medical Device Boston

Boston, MA · On-site

$120 - $160/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Overview AngioSafe is a Bay Area medical device company focusing on improving healthcare delivery ... risk and improve outcomes of arterial disease. We seek Territory Field Managers to drive and ...

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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 Aug 14, 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.

Assistant Project Manager - Medical

IPG Photonics

Marlborough, MA

Full-time

Re-posted 4 days ago

IPG Photonics rating

8.2

Company rating: 8.2 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

130th of 489 rated machine equipment manufacturers

Job description

IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

The Assistant Project Manager supports the planning, coordination, and execution of cross-functional medical device development projects for Integrated Surgical Platforms within IPG Medical Corporation. This role partners closely with Engineering, Regulatory, Quality, Manufacturing, CDMOs, and other stakeholders to help ensure projects are delivered on time, within budget, and in compliance with applicable medical device regulations and design control requirements.

The ideal candidate brings strong project coordination capabilities, technical knowledge of medical device development, and the ability to operate effectively in a fast-paced, regulated product development environment.

Essential Responsibilities
  • Assist in planning, coordinating, and managing cross-functional medical device development projects, including collaboration with external partners, suppliers, and contract manufacturers.
  • Prepare project plans, schedules, status reports, presentations, and supporting materials for review with senior leadership and key stakeholders.
  • Support project execution activities across Engineering, Regulatory, Quality, Manufacturing, and Operations functions.
  • Proactively identify project risks, escalate issues appropriately, and support the development of mitigation and contingency plans.
  • Monitor project progress against established timelines, budgets, and deliverables; assist in implementing corrective actions when needed.
  • Partner with development team members to drive accountability, prioritize activities, and ensure timely completion of project tasks and deliverables.
  • Assist in managing program budgets, forecasting project costs, and tracking actual spending against approved budgets.
  • Support compliance with medical device design control and product development processes, including documentation and change management activities.
  • Ensure project activities, meeting outcomes, decisions, and action items are effectively communicated and documented.
  • Contribute input regarding team collaboration, project execution, and performance observations to Project Managers and functional leaders.
  • Support manufacturing transfer activities for medical products, including coordination of transfer documentation and validation-related activities.
Education
  • Bachelor's degree in Engineering or related technical discipline required.
  • Master's degree preferred.
Experience
  • Minimum of 3 years of project management experience within the medical device industry.
  • Preferred experience supporting single-use medical devices, endoscopes, peripheral equipment, or related surgical systems.
  • Minimum of 3-5 years of overall medical device industry experience preferred.
  • At least 2 years of experience in one or more of the following areas preferred:
    • Endoscopy
    • Digital image processing
    • Systems engineering
  • Experience supporting manufacturing transfer activities for medical products, including:
    • IQ/OQ/PQ validation activities
    • DMR documentation
    • Work Instructions
    • Product Specifications
    • PFMEAs
    • MVPs and related transfer documentation
  • Demonstrated experience supporting medical device development projects in a regulated environment.
  • Experience working within a formal Stage Gate product development process preferred.
  • Proven ability to manage multiple workstreams in a fast-paced development environment.
Technical Skills & Knowledge
  • Working knowledge of Microsoft Project or equivalent project planning software.
  • Strong project planning, reporting, and presentation skills.
  • Excellent written and verbal communication skills.
  • Knowledge of medical device design controls, risk management, and applicable regulations and standards preferred, including:
    • FDA Quality System Regulations (QSR)
    • ISO 13485
    • EU MDR
    • ISO 14971
    • IEC 60601
    • IEC 60825
    • IEC 62366
Core Competencies
  • Cross-functional collaboration
  • Organizational and time management skills
  • Risk identification and problem solving
  • Attention to detail and documentation accuracy
  • Ability to manage competing priorities
  • Strong interpersonal and communication skills
  • Accountability and follow-through
  • Adaptability in a dynamic development environment

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