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Medical Device Risk Management Jobs in Boca Raton, FL

Risk Management Own the project risk register end to end: structured identification workshops ... medical, dental, vision, life, and short-term and long-term disability insurance, as well as paid ...

Provide oversight to Risk Management programs, procedures and documentation for Development and ... A minimum of 4 years of experience in Quality with Pharmaceutical and/or Medical Device based GMP ...

EHS

Hollywood, FL · On-site

$76K - $103K/yr

Conduct risk assessments, safety inspections, and job hazard analyses. * Manage programs such as ... Pharmaceutical, biotechnology, medical device, chemical, or similar industry experience preferred.

Be Seen First

... · Perform complete device inspection by measuring dimensions, such as length, diameter, and ... QA manager and follows up to ensure that corrective action(s) have taken / will take place. · ...

Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre ... US FDA Manage commercial device tracking Develop clinical protocols and clinical study reports ...

Medical Orthopedic Rep

Hollywood, FL · On-site

$91K - $122K/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 ...

Showing results 21-40

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 Sep 10, 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 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 Boca Raton, FL look for?

The top searched job categories for Medical Device Risk Management jobs in Boca Raton, FL are:

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:

Senior Staff Electrical Engineer

Fort Lauderdale, FL • On-site

Stryker Group
IT Services • 1 - 10 employees

$118K - $196K/yr

Other

Posted 23 days ago


Job description

It\'s Time to Join Stryker!

We are seeking a Senior Staff Electrical Engineer to lead the development of a major electrical subsystem for a next generation surgical robotic platform. This hands-on technical leadership role includes PCBA design, system integration, testing, troubleshooting, and mentorship of other engineers.

You will collaborate with Software, Systems, Mechanical Engineering, Quality, Manufacturing, and Regulatory teams to develop reliable electrical solutions from concept through commercialization.

What You Will Do
  • Lead the electrical design and development of a major robotic subsystem.
  • Translate product and system needs into electrical requirements, interfaces, and designs.
  • Develop complex PCBAs, including schematic design, component selection, and rigid, flex, and rigid-flex board designs.
  • Perform PCB layout reviews, board bring-up, characterization, testing, and debugging using Altium.
  • Integrate electrical hardware with embedded software, mechanical components, and the broader robotic system.
  • Lead technical tradeoff decisions involving performance, safety, reliability, manufacturability, cost, and risk.
  • Develop verification and EMC test strategies and support testing at external laboratories or other Stryker facilities.
  • Troubleshoot complex electrical and multidisciplinary system issues.
  • Mentor engineers, lead design reviews, and improve electrical engineering tools and practices.
  • Support design documentation, risk management, design transfer, and product commercialization.
What You Need
  • Bachelor\'s degree in Electrical Engineering or a related engineering discipline is required.
  • Six or more years of professional electrical engineering experience is required.
Preferred Qualifications
  • Advanced PCBA design experience, including schematic design, component selection, layout review, board bring-up, and debugging.
  • Proficiency with Altium and experience with rigid, flex, or rigid-flex board designs.
  • Experience leading the electrical development of a complex product or major subsystem.
  • Experience integrating electrical hardware with software, mechanical systems, and system-level requirements.
  • Knowledge of EMC/EMI design, testing, troubleshooting, and design for manufacturability.
  • Experience developing complex electromechanical, robotic, medical, or other technically sophisticated products.
  • Experience guiding products from requirements and concept development through verification, transfer, and commercialization.
  • Medical device experience, including design controls, risk management, IEC 60601, or Design History File documentation.
  • Demonstrated technical leadership, cross-functional collaboration, and mentorship of other engineers.
  • Strong communication and complex problem-solving skills.
  • $118,000 - $196,700 USD Annual
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