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Medical Device Risk Management Jobs in Boca Raton, FL

atrion

Sr. Manager - Quality Assurance

Davie, FL

Excellent technical writing experience within a medical device environment is essential. * Strong root cause analysis skills. * Ability to use sound scientific judgement and risk management for the ...

UHS

RISK MANAGEMENT COORDINATOR

West Palm Beach, FL · On-site

$15.25 - $20.50/hr

Wellington Regional Medical Center is located in Wellington, Florida. It is a 235-bed, acute care ... In cooperation and coordination with the WRMC Director of Risk Management, is responsible for ...

UHS

RISK MANAGEMENT COORDINATOR

West Palm Beach, FL · On-site

$15.25 - $20.50/hr

Wellington Regional Medical Center is located in Wellington, Florida. It is a 235-bed, acute care ... In cooperation and coordination with the WRMC Director of Risk Management, is responsible for ...

UHS

RISK MANAGEMENT COORDINATOR

West Palm Beach, FL

$15.25 - $20.50/hr

Wellington Regional Medical Center is located in Wellington, Florida. It is a 235-bed, acute care ... In cooperation and coordination with the WRMC Director of Risk Management, is responsible for ...

atrion

Quality Engineering Manager

Davie, FL

Apply basic risk management principles to all aspects of the quality system. Qualifications ... Excellent working knowledge of medical device regulations and industry standards pertaining to ...

atrion

Quality Engineer

Davie, FL

$66K - $85K/yr

Develop and maintain risk management files and quality control plans for components, devices and ... A minimum of 5 years' experience in the medical device manufacturing industry is preferred.

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Boca Raton, FL

Medical Device Risk Management information

See Boca Raton, FL salary details

$48.9K

$105.9K

$161.3K

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 Boca Raton, FL is $105,863.00, according to ZipRecruiter salary data. Most workers in this role earn between $85,400.00 and $122,400.00 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 cities near Boca Raton, FL are hiring for Medical Device Risk Management jobs? Cities near Boca Raton, FL with the most Medical Device Risk Management job openings:
Medical Device Risk Management jobs near you
Engineer II - Medical Device

Engineer II - Medical Device

International Medical Industries

Pompano Beach, FL

Other

Posted 18 days ago

Job description

Description

The Engineer II will be responsible for day-to-day production support, developing, maintaining and improving production processes. Engineers at this level must have prior relevant experience in the medical device industry and are expected to be able to work under general supervision on moderately complex engineering assignments. This role is responsible for improving manufacturing quality, lead time and cost through active problem solving, developing solutions and implementing process changes in accordance with the quality system.


Essential Duties and Responsibilities:

Apply engineering skills to create manufacturing processes or improved established processes.

Develop process characterizations (DOEs), qualifications (TQ/IQ/OQ/PQ/TMV) and PFMEAs.

Prepare manufacturing work instructions and provide training as required.

Responsible for evaluation and analysis of data, lead investigation and documentation of all validation deviations and determine impact on the validations.

May incorporate inspection and test requirements into the production plan.

Perform data analysis and apply statistical techniques to optimize and correct established manufacturing processes as directed. Collect, analyze, & report process data.

Provide technical and engineering support in a manufacturing area.

Evaluate performance of equipment to verify efficiency and investigate and initiate corrective action of problems and deficiencies to ensure product quality.

Develop manufacturing processes that are applicable to statistical process control and may develop those techniques.

Troubleshoot any production problems; assure that equipment and facilities are properly maintained for efficient production; report any process or equipment problems to manufacturing engineering management.

Provide technical and manufacturing engineering support to sustain current production through day-to-day support.

Assure compliance with all regulations and good manufacturing practices.

Perform other duties as assigned.

Requirements

  • Bachelor's Degree or higher in Plastics Engineering, Mechanical Engineering, Manufacturing Engineering or other engineering discipline.
  • 0 years of experience required.
  • Proactive learner.
  • Strong knowledge of polymer materials and their properties.
  • Must have good interpersonal and communication skills.
  • Proficient in CAD, Word, Excel, and PowerPoint.

Preferred Job Qualifications:

  • Knowledge of scientific molding principles.
  • Certification in plastics engineering or related field.

Physical / Mental Demands:

Working conditions are normal for an office environment.

Work may require weekend and evening work.

Work may require travel.

Physical activity includes sitting, walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 pounds.

Work under stress in a fast-paced environment.

Must be alert, able to concentrate, and use good judgment.

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