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Medical Device Risk Management Jobs in California

Hologic

Quality Engineer 4 - Risk Management

San Diego, CA · On-site

$76K - $98K/yr

Strong knowledge of medical device and/or IVD risk management principles across the full product lifecycle. * Advanced understanding of applicable regulatory and quality system requirements ...

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 ...

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 ...

Adventist Health

Risk Management Specialist

Ukiah, CA · On-site

Risk Management, Claims, Legal, Patient Safety, Quality, Accreditation, Regulatory, and Licensing ... identify medical device and equipment failures for purposes of improving organizational risk ...

Hologic

Quality Engineer 3 - Risk Management

San Diego, CA · On-site

$76K - $98K/yr

This role is responsible for performing and maintaining product and process risk management activities for medical device and/or in-vitro diagnostic products across the full product lifecycle. The ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in California

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 Jun 29, 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 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 California? For Medical Device Risk Management jobs in California, the most frequently searched job titles are:
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
Risk Management Specialist - Design Controls Remediation

Risk Management Specialist - Design Controls Remediation

Intellectt INC

San Diego, CA • On-site

Contractor

Posted 11 days ago

Job description

Job Title: Risk Management Specialist – Design Controls Remediation
Industry: Medical Device
Engagement: Contract

Job Overview

The Risk Management Specialist will support design controls remediation activities by ensuring appropriate evaluation and documentation of product risks throughout retrospective design reviews and remediation updates. This role provides subject matter expertise in medical device risk management and ensures alignment with regulatory expectations under FDA Quality Management System Regulation (QMSR) and ISO 14971.

The specialist will collaborate with cross-functional teams to assess risk considerations in existing design documentation, address documentation gaps, and ensure risk-based decision making is properly documented during remediation activities.

Key Responsibilities

  • Provide risk management expertise across design controls remediation workstreams.
  • Review existing design documentation to ensure product risk has been appropriately assessed and documented.
  • Support retrospective risk evaluations within design documentation as part of remediation efforts.
  • Assist in developing risk-based justifications where documentation gaps or inconsistencies are identified.
  • Ensure risk considerations are incorporated into documentation updates and remediation activities.
  • Provide guidance to ensure alignment with FDA QMSR and ISO 14971 risk management expectations.
  • Collaborate with cross-functional teams including Quality, Regulatory, R&D, and Engineering.
  • Support integration of risk perspectives across design review and documentation processes.

Required Qualifications

  • Experience in risk management within medical device development environments.
  • Experience supporting design controls remediation or quality remediation initiatives.
  • Strong understanding of risk management principles and methodologies.
  • Hands-on experience applying ISO 14971 risk management processes.
  • Familiarity with FDA QMSR and global regulatory frameworks.
  • Experience reviewing design documentation with risk-based considerations.

Preferred Qualifications

  • Experience working within Design Controls, Design Assurance, or Quality Engineering teams.
  • Experience supporting FDA inspection readiness or regulatory remediation projects.
  • Strong cross-functional collaboration and documentation review skills.