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Iso 14971 Jobs (NOW HIRING)

Omnex Inc

Omnex Consultant ISO 13485

Ann Arbor, MI · On-site

$80 - $100/hr

Risk Management (ISO 14971 & ISO 24971) * SaMD (Software as a Medical Device), & SiMD (Software in a Medical Device) * IEC ISO 62304 * FDA Guidance * IMDRF Guidance * Cybersecurity Guidance * Core ...

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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.

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Infographic showing various Iso 14971 job openings in the United States as of September 2026, with employment types broken down into 92% Full Time, 2% Part Time, 4% Contract, and 2% Nights. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution.

R&D Engineer (medical device) (ISO 13485, ISO 14971

Franklin Lakes, NJ • On-site

ConfigUSA
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Contractor

Re-posted 24 days ago

Job description

R&D Engineer

Prior experience mandatory in medical devices domain, Plan & execute validation activities in alignment with ISO 13485, ISO 14971, Responsible for managing and overseeing the daily operations and projects at a clients location, acting as the primary link between the client, project team, Experience in R&D New product development & Design Change Management.

Experience in Product life cycle management, developing, Risk Management activities Design Verification & validation activities