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Medical Device Risk Management Jobs in California

BEPC INC

Be Seen First

Medical Device Assembler - 30531

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA 92591 Employment Type: W2 Contract - 12 Months with ... management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in ...

Holland Hospital

BA or BS in risk management, healthcare administration, or a related field Preferred * Masters ... Safe Medical Device Act, etc. * Oversee accreditation and continuous readiness activities in ...

New

Applied Medical

CAPA Engineer

Rancho Santa Margarita, CA · On-site

$72K - $78K/yr

... medical device quality through investigation of non-conformances, root cause analysis, risk ... Demonstrating a strong understanding of Applied's Quality Management System (QMS) and effectively ...

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Medical Device Risk Management information

See California salary details

$50.8K

$110.1K

$167.8K

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

As of Sep 10, 2026, the average yearly pay for medical device risk management in California is $110,095.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,800.00 and $127,300.00 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 California look for?

The top searched job categories for Medical Device Risk Management jobs in California are:

What cities in California are hiring for Medical Device Risk Management jobs?

Cities in California 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 California as of September 2026, with employment types broken down into 1% As Needed, 62% Full Time, 32% Part Time, and 5% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $110,095 per year, or $52.9 per hour.

Senior Manager, Clinical Product Quality - Medical Device/Complaint Handling & Cardiovascular RN

Irvine, CA • On-site

Edwards Lifesciences Corporation
Medical Equipment and Supplies Manufacturing • 10K+ employees
Learn more about Edwards Lifesciences Corporationexternal

Full-time

Posted 8 days ago

Edwards Lifesciences rating

8.2

Company rating: 8.2 out of 10

Based on 31 frontline employees who took The Breakroom Quiz

Job description

This position offers the flexibility of being fully remote, but the selected candidate must be currently residing within the United States.
Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As a Senior Manager, Clinical Product Quality, you will be a member of Complaint Handling and Post Market Surveillance/Risk Management team to provide clinical guidance/clinical expert knowledge to Quality, Engineering and other cross functional teams to understand the nature of complaints and possible health risks. In this role you will ensure appropriate investigation of product complaints and adverse events, in order to escalate potential manufacturing, design, labeling and training issues. You will also follow standard practices and procedures in analyzing data, interpreting and drawing conclusions, with the objective of gathering key information and communicating to cross-functional teams who will utilize the information for improvement of product and procedural outcomes.
How you will make an impact:
  • Provides medical/clinical guidance to complaint investigators and engineers related to event interpretation, event investigation, proper coding, required regulatory reporting (Medical Device Reports, Medical Device Vigilance, etc.), and complaint closure. Author and/or review complaint conclusions/closure statements and customer letters. May assist with and help manage Imaging Reviews
  • Educates complaint investigators to understand nature of events and possible health risks
  • Interprets complaint data for complaint investigators, engineers, and other Quality department personnel
  • Authors clinically based product specific scripts to guide complaint investigators in appropriate investigational paths
  • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution
  • Provides training to complaint investigators on patient anatomy and medical conditions, and IHFM (Implantable Heart Failure Management) products and procedure
  • Provides complaint training to Sales, Marketing and other customer facing roles
  • Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions.
  • Reviews complaint codes and FDA Medical Device Reports, reviews and assists with reporting decisions
  • Authors and/or reviews complaint conclusions/closure statements and customer letters
  • Analyzes and interprets complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report
  • Performs Complaint Trending Analyses and participates in Quality Metrics Review and Quality Data Review meetings where complaints are discussed
  • Communicates complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations
  • Participates in review of/provides clinical guidance for FMEAs (Failure Mode & Effects Analysis) and Risk Management Worksheets
  • Provides clinical input to Product Risk Assessments, and participate in Risk Management Councils and Quality Boards
  • Aid in response to Regulatory Agencies who inquire about complaint /Risk Management related issues

What you'll need (Required):
  • Bachelor's degree plus 10 years of relevant experience or equivalent work experience based on Edwards' criteria
  • Registered Nurse (RN) - current state license active or expired
  • Cardiac patient care experience (e.g. cardiac care, ICU, OR, or cardiovascular interventions)
  • Medical device industry experience in Quality/Compliance, with a strong preference for complaint handling, complaint investigation, and/or post-market surveillance

What else we look for (Preferred):
  • RN with Cath Lab, CVOR, or CVICU nursing experience
  • Expert knowledge of the FDA's Quality System Regulations; experience working within a Quality Management System. Strong working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, CMDR, MDD 93/42/EEC, and other applicable regulatory requirements.
  • Demonstrated subject matter expertise in clinical product quality, complaint handling, post-market surveillance, risk management, escalation, field action or related quality processes.
  • Proven successful project management and cross-functional leadership skills.
  • Ability to read and interpret documents such as Product Instructions for Use, Training and Procedure Manuals
  • Ability to write routine MDR (Medical Device Reports)/MIR (Manufacturer Incident Report) and routine correspondence
  • Ability to interpret patient medical records and clinical data to assess adverse events and potential device-related risks
  • Ability to speak effectively before groups of employees of organization
  • Ability to provide technical guidance, coaching, and feedback to peers and cross-functional partners without direct people-management responsibility.
  • Experience in developing or delivering training programs
  • Knowledge of computer application programs including Excel, PowerPoint and Word
  • Excellent written and oral English communication skills

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The base pay range for this position is $145,000 to $205,000(highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

What Edwards Lifesciences employees say

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Hours and flexibility

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About Edwards Lifesciences

Sourced by ZipRecruiter

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Irvine, CA, US

Year founded

1958

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