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Iso 14971 Jobs in San Ramon, CA (NOW HIRING)

Epia Neuro

Senior Quality Engineer

Alameda, CA · On-site

$120 - $180/hr

You'll bring hands-on software quality engineering experience to support our software and firmware teams in meeting IEC 62304, ISO 14971, and ISO 13485/FDA QMSR requirements throughout the product ...

Mizuho OSI

Quality Assurance Engineer

Union City, CA · On-site

The position utilizes technical expertise on the FDA's QMSR, ISO 13485, ISO 14971, EU MDR for Class I and Class II medical devices for capital equipment and their accessories. The QA Engineer ...

Mizuhosi

Quality Assurance Engineer

Union City, CA · On-site

$136 - $156/hr

The position utilizes technical expertise on the FDA's QMSR, ISO 13485, ISO 14971, EU MDR for Class I and Class II medical devices for capital equipment and their accessories. The QA Engineer ...

Mizuho OSI

Quality Assurance Engineer

Union City, CA · On-site

The position utilizes technical expertise on the FDA's QMSR, ISO 13485, ISO 14971, EU MDR for Class I and Class II medical devices for capital equipment and their accessories. The QA Engineer ...

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All JobsIso 14971 JobsIso 14971 Jobs in San Ramon, CA

Iso 14971 information

What is ISO 14971?

ISO 14971 is an international standard that outlines the requirements for risk management in the design and production of medical devices. It provides a systematic process for identifying, evaluating, and controlling risks to ensure the safety of patients, users, and others involved with medical devices. Compliance with ISO 14971 is often required by regulatory bodies and helps manufacturers demonstrate that they have taken appropriate steps to minimize potential hazards associated with their products.

What are the common challenges faced by professionals implementing ISO 14971 in medical device companies?

One of the main challenges in implementing ISO 14971 is ensuring cross-functional collaboration between engineering, quality assurance, regulatory, and clinical teams to comprehensively identify and manage risks throughout the product lifecycle. Professionals often face the task of translating complex technical data into clear risk management documentation that meets regulatory expectations. Keeping up with evolving regulations and maintaining consistent risk management practices across multiple projects can also be demanding. Effective communication and ongoing training are essential to successfully embed ISO 14971 processes into everyday operations.

What are the key skills and qualifications needed to thrive as an ISO 14971 risk management specialist, and why are they important?

To thrive as an ISO 14971 Risk Management Specialist, you need a strong understanding of risk management principles, regulatory standards for medical devices, and a relevant science or engineering background. Experience with risk assessment tools, quality management systems (such as ISO 13485), and familiarity with documentation software are typically required. Excellent analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These capabilities are critical to ensuring compliance, patient safety, and the successful commercialization of medical devices.

What is the difference between Iso 14971 vs Medical Device Quality Engineer?

AspectIso 14971Medical Device Quality Engineer
CertificationsISO 14971 certification, risk management trainingISO 13485, Six Sigma, quality management certifications
Work EnvironmentRegulatory compliance, risk assessment in medical device developmentQuality assurance, process improvement, audits in medical device manufacturing
Industry UsageUsed by regulatory professionals and risk managersUsed by quality assurance and engineering teams

While Iso 14971 focuses on risk management standards for medical devices, a Medical Device Quality Engineer ensures overall product quality and compliance. Both roles are essential in the medical device industry but serve different functions—one emphasizes risk assessment, the other quality assurance.

What job categories do people searching Iso 14971 jobs in San Ramon, CA look for?

The top searched job categories for Iso 14971 jobs in San Ramon, CA are:

What cities near San Ramon, CA are hiring for Iso 14971 jobs?

Cities near San Ramon, CA with the most Iso 14971 job openings:

Iso 14971 jobs near you
Infographic showing various Iso 14971 job openings in San Ramon, CA as of August 2026, with employment types broken down into 89% Full Time, 4% Part Time, 5% Contract, and 2% Nights. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution.

Software Design Control Engineer

Jobtailor

San Francisco, CA • On-site

$130 - $190/hr

Other

Posted 10 days ago

Job description

  • Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
  • Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485, and FDA 21 CFR Part 820 regulations.
  • Author and maintain software risk management files, including Software FMEAs per ISO 14971.
  • Produce software verification and validation (V&V) protocols and reports in coordination with the engineering and test teams to ensure full traceability.
  • Compile and organize necessary software technical documentation for regulatory submissions.
  • Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.
Requirements
  • 5+ years of experience in the medical device industry, specifically working with software‑driven or connected medical devices (Class II or Class III).
  • A Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
  • Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
  • Proven track record of taking a medical device software product through a successful FDA clearance/approval process and subsequent launch.
  • Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
  • Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
Core Competencies

Expertise in authoring and managing medical device software documentation, including compliance with IEC 62304, ISO 14971, and FDA regulations. Proven ability to navigate the FDA clearance process for software‑driven medical devices.

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