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Medical Device Risk Management Jobs in California

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 ...

Crown Medical, Inc.

Medical Device Rep

Carlsbad, CA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Ability to effectively manage a physician-based customer base * Skills to communicate clinically ...

Crown Medical, Inc.

Medical Device Rep

Santa Barbara, CA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Ability to effectively manage a physician-based customer base * Skills to communicate clinically ...

SlingShot Connections

Be Seen First

Medical Device Assembler

San Clemente, CA · On-site

$22.10/hr

Work under direction from management or engineering staff with direct oversight * Other duties as ... Comfortable working in a regulated environment (medical device experience is a plus) * Ability to ...

Jj

Sr Specialist, Clinical Risk Management

Irvine, CA · On-site

$39.25 - $52.25/hr

The Sr. Specialist, Clinical Quality Risk Management works to support the Clinical Quality Risk ... Medical device/MedTech industry or equivalent healthcare industry experience * Strong working ...

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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 Aug 15, 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
Infographic showing various Medical Device Risk Management job openings in California as of August 2026, with employment types broken down into 70% Full Time, 10% Part Time, and 20% Temporary. Highlights an 90% In-person, and 10% Remote job distribution, with an average salary of $110,095 per year, or $52.9 per hour.

Quality Engineer 3 - Risk Management

Hologic

San Diego, CA • On-site

$76K - $98K/yr

Full-time

Re-posted 22 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

176th of 489 rated machine equipment manufacturers

Job description


The Quality Engineer Level 3 - Risk Management is an experienced individual contributor within Regulatory and Quality for Diagnostics. 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 position supports new product development, sustaining activities, manufacturing, supplier quality, post-market surveillance, complaints, CAPA, nonconformances, and change management.
The role partners with cross-functional teams, including Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post-Market teams, to ensure risk management activities are completed in accordance with applicable quality system requirements, FDA regulations, ISO 13485, ISO 14971, and other relevant medical device and IVD regulatory expectations.
Knowledge
  • Product and process risk management principles for medical devices and IVD products.
  • FDA Quality System requirements and applicable regulatory expectations.
  • ISO 13485 and ISO 14971 requirements.
  • QSR, CDRH, IVDR, MDR, MDSAP, and IEC 62304 regulations and standards.
  • Design controls and their relationship to risk management.
  • Hazard analysis, use-related risk assessment, fault tree analysis, DFMEA, PFMEA, safety risk analysis, product risk assessments, and benefit-risk evaluations.
  • Complaint handling, CAPA, nonconformance, change control, validation, and post-market surveillance processes.
  • Root cause analysis and corrective action methods.
  • Technical documentation, including requirements, specifications, verification and validation reports, manufacturing procedures, quality records, and risk files.
  • Audit and inspection readiness expectations for internal audits, external audits, regulatory inspections, and supplier audits.

Skills
The successful candidate should demonstrate the ability to:
  • Independently perform assigned risk management activities across product development, manufacturing, sustaining, and post-market lifecycle phases.
  • Develop, review, maintain, and evaluate risk management documentation and deliverables.
  • Assess whether product, process, software, supplier, manufacturing, service, or labeling changes introduce new hazards or affect existing risk controls.
  • Identify, verify, and evaluate the effectiveness of risk controls.
  • Interpret technical documentation and identify quality, compliance, or risk implications.
  • Produce clear, objective, technically accurate, and inspection-ready documentation.
  • Apply analytical thinking, problem-solving, root cause analysis, and risk-based decision-making.
  • Support cross-functional teams, design reviews, change review boards, CAPA teams, complaint investigations, and material review activities.
  • Provide subject matter input during audits, inspections, and readiness activities.
  • Manage multiple priorities and meet project timelines in a dynamic regulated environment.
  • Communicate effectively through written, verbal, and interpersonal interactions.

Behavior
  • Works independently on defined assignments while recognizing when escalation is needed.
  • Demonstrates strong attention to detail and a commitment to high-quality standards.
  • Collaborates effectively with stakeholders across Quality, Regulatory, R&D, Manufacturing, Supplier Quality, Customer Service, Commercial/Sales, and Post-Market teams.
  • Maintains objectivity and technical accuracy in risk documentation and assessments.
  • Supports a culture of compliance, inspection readiness, and continuous improvement.
  • Escalates complex risk questions, safety concerns, or unresolved risk acceptability issues to management or senior technical leaders.
  • Contributes constructively to cross-functional decision-making and risk-based discussions.
  • Adapts to changing priorities while maintaining focus on quality, compliance, and product safety.

Experience
  • A minimum of a Bachelor's degree in engineering, life sciences, biomedical sciences, quality, or a related technical discipline.
  • 5+ years of related experience in a regulated medical device, IVD, quality engineering, or product development environment.
  • Experience supporting risk management files, hazard analyses, FMEAs, design control documentation, change control, complaints, CAPA, and/or nonconformance processes.
  • Experience working on cross-functional teams in regulated product development or sustaining engineering environments.
  • Experience evaluating post-market information such as complaints, deviations, nonconformances, service data, and other feedback for potential risk impact.
  • Experience supporting internal audits, external audits, regulatory inspections, supplier audits, and inspection readiness activities.
  • Practical experience reviewing and maintaining risk files throughout product development, manufacturing, and post-market surveillance phases.

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $98,500 - $154,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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