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Medical Device Risk Management Jobs (NOW HIRING)

ESR Healthcare

Medical Device Assembler

Minnetonka, MN · On-site

$18.25 - $22.50/hr

Medical Device Assembler Medical Device Assembler Shift Timings: Mon-Thur | 5am to 3pm Pay Rate: 18 ... Communicate clearly with supervisors, managers, and team members regarding issues, ideas, and ...

AtWork Personnel North Gwinnett

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Medical Device Assembler

Buford, GA · On-site

$17.50/hr

Candidates with clean room, medical device, electronics, or precision manufacturing experience are ... We connect talented professionals with rewarding entry-level and management roles at some of the ...

Lancesoft

Device Engineer III

Foster City, CA · On-site

$70 - $100.72/hr

Additional responsibilities include post market surveillance reports, risk management file ... Working knowledge of relevant US, EU, and international medical device and pharmaceutical ...

AngioSafe

Medical Device R&D Engineer

San Jose, CA · On-site

$115K - $175K/yr

... medical device company. Roles and Responsibilities * Contribute to the design, development, testing ... risk management documentation * Work closely with suppliers to support component development and ...

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 ...

AngioSafe

Medical Device R&D Engineer

San Jose, CA · On-site

$115K - $175K/yr

... medical device company. Roles and Responsibilities * Contribute to the design, development, testing ... risk management documentation * Work closely with suppliers to support component development and ...

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Medical Device Risk Management information

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$51.5K

$111.6K

$170K

How much do medical device risk management jobs pay per year?

As of Jun 6, 2026, the average yearly pay for medical device risk management in the United States is $111,556.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,000.00 and $129,000.00 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.
More about Medical Device Risk Management jobs
What cities are hiring for Medical Device Risk Management jobs? Cities with the most Medical Device Risk Management job openings:
What states have the most Medical Device Risk Management jobs? States with the most job openings for Medical Device Risk Management jobs include:
What job categories do people searching Medical Device Risk Management jobs look for? The top searched job categories for Medical Device Risk Management jobs are:
Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in the United States as of May 2026, with employment types broken down into 3% Locum Tenens, 3% As Needed, 43% Full Time, and 51% Part Time. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $111,556 per year, or $53.6 per hour.

Sr. Quality Engineer - Medical Device Manufacturing

MICRON PRODUCTS INC & SUBSIDIARIES

Fitchburg, MA • On-site

$89K - $121K/yr

Full-time

Medical, Retirement, PTO

Posted 15 days ago

Job description

Micron Solutions is a multifaceted contract manufacturing organization specializing in thermoplastic injection molding, precision machining and finishing, and silver-plated medical sensors for disposable electrodes. We collaborate with clients of all sizes to provide manufacturing solutions and assembly services that support their goals from concept to commercialization. Our 120,000 square foot Fitchburg, MA facility is equipped to manage projects across the full product lifecycle.

The Senior Quality Engineer ensures compliance with FDA regulations, ISO 13485 standards, and customer requirements for the manufacturing and assembly of molded and machined components, including medical device components and assemblies. This role is responsible for maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting product quality throughout the lifecycle. The engineer serves as a technical expert in risk management, process controls, and regulatory compliance.

What We Offer:

  • Competitive salary 
  • Comprehensive benefits package, including health insurance, 401(k), and paid time off.

KEY ACCOUNTABILITIES

Regulatory & Quality Compliance

  • Maintain and enhance QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
  • Lead internal, customer, and regulatory audit activities,; including preparation and response..
  • Ensure adherence to Good Manufacturing Practices (GMP) and risk-based quality approaches.

Process & Product Quality

  • Develop and implement quality plans, inspection methods, and control plans for medical device components.
  • Lead root cause analysis and corrective/preventative actions (CAPA) for nonconformances and complaints.
  • Collaborate with engineering and production teams on new product launch introductions, including process validation (IQ/OQ/PQ) and equipment qualification.

Risk Management & Documentation

  • Conduct risk assessments per ISO 14971 and maintain risk files.
  • Prepare and maintain quality documentation, including Device History Records (DHR), validation reports, and audit findings.
  • Ensure proper document control and traceability for all components and assemblies.

Continuous Improvement

  • Drive initiatives using Lean, Six Sigma, and statistical methods to reduce defects and improve yield.
  • Analyze quality metrics (scrap, rework, complaints) and implement corrective actions.

Customer & Supplier Interface

  • Serve as primary quality contact for medical device OEM customers, addressing concerns and ensuring satisfaction.
  • Support supplier quality activities, including qualification, audits, and performance monitoring.

JOB QUALIFICATIONS

Education:

Bachelor’s degree in Engineering (Mechanical or Industrial preferred)

Experience:

  • Minimum 7+ years in quality engineering within medical device manufacturing or assembly
  • Strong knowledge of ISO 13485, FDA QMSR, and risk management principles

Skills:

  • Proficiency in lean principles and continuous improvement methodologies.
  • Strong computer  skills ( MS Office, ERP systems, electronic QMS systems).
  • Expertise in quality tools: Root Cause Analysis, SPC, FMEA, MSA, GD&T.
  • Experience with metrology, process validation and statistical analysis
  • Excellent problem-solving, analytical, organizational and communication skills.

Preferred Certifications

  • ASQ Certified Quality Engineer (CQE)
  • Six Sigma Green/Black Belt

Core Competencies

  • Leadership and team collaboration
  • Strong attention to detail and compliance
  • Continuous improvement mindset
  • Ability to manage multiple priorities independently in a regulated environment

Please note: This position is not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship requirements.

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