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Medical Devices Risk Management Jobs (NOW HIRING)

BSI Group

If you have hands on experience in the Research, Design or Manufacture of Active Medical Devices we ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Prof Serv EHS West

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Group

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Group

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Prof Serv EHS West

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Group

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Prof Serv EHS West

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Prof Serv EHS West

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Group

Global Homebased BSI is seeking experienced R&D Engineers to join our Active Medical Devices team ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

Jj

Associate Manager, Risk Management, EMS

Danvers, MA · On-site

Support risk management lead and category managers to develop Business Continuity Plans for high ... Strong Business Acumen with Medical Devices (specifically Abiomed relevant industry) experience ...

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All JobsMedical Devices Risk Management Jobs

Medical Devices Risk Management information

See salary details

$51.5K

$111.6K

$170K

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

As of Jun 15, 2026, the average yearly pay for medical devices 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 is the highest paying risk management job?

In the field of medical devices risk management, senior roles such as Risk Management Directors or Chief Risk Officers typically have the highest salaries, often exceeding six figures. These positions require extensive experience, certifications like ISO 14971, and leadership skills, reflecting their strategic importance and responsibility within organizations.

How much does a risk manager get paid?

A risk manager in the medical devices industry typically earns between $80,000 and $130,000 annually, depending on experience, location, and certifications such as ISO 14971 or ISO 13485. Senior risk managers or those in high-demand regions can earn higher salaries, often exceeding $150,000.

What is risk management in medical devices?

Risk management in medical devices involves identifying, evaluating, and controlling potential hazards throughout the device's lifecycle to ensure safety and effectiveness. Professionals in this field use standards like ISO 14971 and perform risk assessments to minimize harm to patients and users. It is a critical part of regulatory compliance and quality assurance in medical device development.

What are the main challenges faced by professionals in Medical Devices Risk Management, and how are they typically addressed?

Professionals in Medical Devices Risk Management often face challenges related to keeping up with evolving regulatory requirements, managing cross-functional communication, and ensuring comprehensive risk assessments throughout the product lifecycle. Navigating frequent updates to standards such as ISO 14971 and integrating feedback from engineering, clinical, and quality teams can be complex. To address these challenges, risk managers rely on robust documentation practices, regular team training, and close collaboration with regulatory affairs and product development teams to ensure compliance and patient safety.

What is medical devices risk management?

Medical devices risk management is the systematic process of identifying, evaluating, controlling, and monitoring risks associated with the use of medical devices throughout their lifecycle. It aims to ensure that any potential harm to patients or users is minimized by implementing appropriate risk control measures. This process is guided by international standards such as ISO 14971 and is essential for regulatory compliance and patient safety. Risk management activities begin during the device design phase and continue through manufacturing, post-market surveillance, and product retirement.

What are the key skills and qualifications needed to thrive as a Medical Devices Risk Management professional, and why are they important?

To excel in Medical Devices Risk Management, you need a solid understanding of regulatory standards (such as ISO 14971), engineering principles, and risk assessment methodologies, often supported by a degree in engineering, life sciences, or a related field. Familiarity with risk management software, quality management systems (QMS), and relevant certifications like Certified Quality Engineer (CQE) or Regulatory Affairs Certification (RAC) is typically required. Strong analytical thinking, attention to detail, and effective communication skills help professionals identify risks and collaborate across departments. These competencies are crucial for ensuring product safety, regulatory compliance, and successful market access.

Is healthcare risk management a good career?

Healthcare risk management, including roles in medical devices risk management, is a growing field that involves identifying and mitigating risks to ensure patient safety and regulatory compliance. It requires knowledge of industry standards, risk assessment tools, and often certifications such as RAC or CRMP. The career offers stability, opportunities for advancement, and the chance to impact healthcare quality positively.

What is the difference between Medical Devices Risk Management vs Medical Devices Quality Assurance?

AspectMedical Devices Risk ManagementMedical Devices Quality Assurance
CertificationsISO 14971, RACISO 13485, RAC
Work EnvironmentRegulatory, R&D, ComplianceManufacturing, Compliance, Inspection
Industry UsageRisk assessment, mitigation planningProduct quality, process control

Medical Devices Risk Management focuses on identifying and mitigating risks associated with medical devices, ensuring safety and compliance. Medical Devices Quality Assurance emphasizes maintaining product quality through standards and inspections. While both roles collaborate to ensure device safety, risk management is proactive in risk assessment, whereas quality assurance concentrates on quality control throughout production.

Infographic showing various Medical Devices Risk Management job openings in the United States as of June 2026, with employment types broken down into 45% Full Time, and 55% 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.

Project Manager Embedded Systems & Medical Devices

Accord Technologies Inc.

San Diego, CA • On-site

Contractor

Posted 10 days ago

Job description

Project Manager – Embedded Systems & Medical Devices
Location: San Diego, California, USA
nsite work only
Any Visa is fine

Must have Medical Devices domain only

Role Overview:

We are seeking an experienced Project Manager to lead a cross-functional medical device development program covering firmware updates, PC software development, hardware qualification, and manufacturing release. The role owns end-to-end delivery while ensuring compliance with design control and quality system requirements.

Key Responsibilities:

  • Lead and coordinate multiple parallel workstreams:
    • Bluetooth module replacement for C6 (MCOT) sensor
    • Firmware updates for C6 (MCOT) and ePatch 2.5 sensors
    • Development and release of a PC application tool
    • Mechanical qualification activities for A15 and A17 monitors
  • Develop and manage integrated project plans, schedules, dependencies, and risks.
  • Ensure compliance with Design Controls (including SOP-19) as required and quality processes.
  • Coordinate Verification & Validation (V&V) planning, execution, and documentation.
  • Act as the primary interface with cross-functional teams(Firmware, Electrical, Mechanical, QA, RA, Manufacturing) and external partners.
  • Drive release readiness and transition from development to manufacturing.
  • Provide regular project status reporting and stakeholder communication.

Education & Experience Required:

  • Bachelor’s degree in Engineering (Electrical, Electronics, Computer Science).
  • 8–12 years of overall experience, with 5+ years in project or program management for software/firmware or embedded systems projects.
  • Proven experience managing projects in regulated environments (medical devices, healthcare, or similar).
  • Hands-on experience working under formal design control processes and quality systems.
  • Experience coordinating cross-functional and external teams, including QA, RA, Manufacturing, and third-party partners.

Required Skills & Competencies:

  • Strong project planning, execution, and risk management skills.
  • Experience driving software and firmware development lifecycles.
  • Working knowledge of V&V activities, design documentation, and release processes.
  • Technical awareness of embedded systems, firmware (ARM/C), PC applications (C/C++/C#), and hardware-software integration.
  • Excellent communication and stakeholder management skills.

Preferred Experience:

  • Medical device product development and manufacturing release.
  • Firmware updates involving Bluetooth modules, battery management, or component obsolescence.
  • Experience interfacing with customers and third-party vendors.