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Medical Device Risk Management Jobs in Pleasanton, CA

Abbott

Engineer, Design Assurance

Pleasanton, CA · On-site

$120 - $150/hr

Strong knowledge of ISO 14971 and medical device risk management principles. * Experience working in a cross-functional and matrixed environment. * Strong communication, analytical, organizational ...

Abbott

Engineer, Design Assurance

Pleasanton, CA · On-site

Strong knowledge of ISO 14971 and medical device risk management principles. * Experience working in a cross-functional and matrixed environment. * Strong communication, analytical, organizational ...

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 ...

AngioSafe

Medical Device R&D Engineer

San Jose, CA

$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

Senior Medical Device R&D Engineer

San Jose, CA · On-site

$150K - $225K/yr

... risk management documentation * Work directly with suppliers to support component development and ... Minimum 10 years of medical device R&D experience * Strong working knowledge of ISO 13485 regulated ...

AngioSafe

Senior Medical Device R&D Engineer

San Jose, CA · On-site

$110 - $150/hr

... risk management documentation * Work directly with suppliers to support component development and ... Minimum 10 years of medical device R&D experience * Strong working knowledge of ISO 13485 regulated ...

AngioSafe

Senior Medical Device R&D Engineer

San Jose, CA · On-site

$150K - $225K/yr

... risk management documentation * Work directly with suppliers to support component development and ... Minimum 10 years of medical device R&D experience * Strong working knowledge of ISO 13485 regulated ...

AngioSafe

Senior Medical Device R&D Engineer

San Jose, CA · On-site

$150K - $225K/yr

... risk management documentation * Work directly with suppliers to support component development and ... Minimum 10 years of medical device R&D experience * Strong working knowledge of ISO 13485 regulated ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Pleasanton, CA

Medical Device Risk Management information

See Pleasanton, CA salary details

$57.3K

$124.2K

$189.2K

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

As of Aug 26, 2026, the average yearly pay for medical device risk management in Pleasanton, CA is $124,151.00, according to ZipRecruiter salary data. Most workers in this role earn between $100,200.00 and $143,600.00 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 Pleasanton, CA look for?

The top searched job categories for Medical Device Risk Management jobs in Pleasanton, CA are:

What cities near Pleasanton, CA are hiring for Medical Device Risk Management jobs?

Cities near Pleasanton, CA with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you

UI/Human Factors Engineer 3 as 100% Remote

Amicis Global

Sunnyvale, CA • Remote

$75/hr

Contractor

Re-posted 25 days ago

Job description

Job Title: UI/Human Factors Engineer 3
Location: Remote
Duration: 10 Months
Pay Rate: $65.00 - $75.00/- on W2
 
 
Kindly help us with your most updated Resume.
 
 

Summary:

As part of the Client Human Factors team, The Human Factors Design Controls Engineer works closely with fellow HF team members and department leadership, as well as collaborates with, clinical engineers, interaction designers, system and software engineers, product managers, project management and technical publications, in addition to regulatory and quality. The Human Factors Design Controls Engineer is a key contributor to inform, guide development of, and maintain usability engineering documentation produced during projects within Design Controls. This role supports the Human Factors Engineering team with expertise in design controls and content creation in tools such as Polarion and Agile, and helps to create the usability engineering documentation required for submission to global medical device regulatory agencies.
This role provides dedicated support and subject matter expertise guidance to the broader human factors engineering team serving all business units and reports to a Sr. Human Factors staff member.

Roles and Responsibilities:

Assist in planning and organization for multiple product risk assessment document remediation efforts running in parallel for a set grouping of risk analysis documents
Analyze existing risk analysis documents for remediation into new risk assessment document formats, including editing and revising risks per Intuitive risk management process and standards.
Support Quality Engineering in collating, editing and improving large amounts of risk line items using efficient methods within a standardized methodology for document remediation.
Assess and prioritize plans for working on multiple documents in parallel, according to emergent needs of document content that may require mode or less effort to refine and improve content.
Skill/Job Requirements:
Minimum of 5 years of related experience with a bachelor's degree
Relevant work experience in human factors engineering, clinical engineering, product design engineering, quality engineering, design controls, risk management and medical device product development.
Strong experience working with design controls project collaboration tools is required. (e.g. Polarion, Agile, Smartsheets etc.).
Knowledge and experience working within medical device design controls process and documentation methodologies, compliant with medical device quality management system regulation (QSMR 13485)
Demonstrable knowledge in medical device risk analysis principles and practices, and risk analysis documentation according to ISO14971 and 62366.
Ability to collaborate with and across various groups and levels of management within the organization.
Strong verbal communication and data analysis skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms).
Ability to travel domestically (up to 10%) to onsite locations if remote.

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