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Medical Device Risk Management Jobs in Boca Raton, FL

Crown Medical, Inc.

Medical Device Rep

Boca Raton, FL · On-site

$82K - $113K/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 ...

atrion

Sr. Manager - Quality Assurance

Davie, FL · On-site

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 ...

atrion

Quality Engineering Manager

Davie, FL · On-site

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 · On-site

$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 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:

Medical Device Risk Management jobs near you

Senior Medical Device Engineer

Fort Lauderdale, FL

ttg Talent Solutions
Recruiting and Staffing Services • 11 - 50 employees
Learn more about ttg Talent Solutionsexternal

$110K - $130K/yr (+ commission)

Full-time

Retirement, PTO

Posted 13 days ago

Job description

Senior Medical Device Engineer
Well-established U.S. pharmaceutical R&D - Global
Western Broward County - South Florida
Relocation assistance 
On-site | Full-time
 
ttg Talent Solutions is conducting a confidential search for a Senior Medical Device Engineer for a well-established U.S. pharmaceutical R&D center that is part of a global organization with a broad portfolio spanning generic, complex generic, and branded drug products. This hands-on role sits at the intersection of medical device engineering and pharmaceutical science, with a particular focus on inhalation and nasal drug-delivery systems, including dry powder inhalers (DPIs), metered-dose inhalers (MDIs), nasal sprays, and nebulizers.
Position Summary
The Senior Device Engineer will serve as the primary device and primary-packaging subject-matter expert within a cross-functional drug-product development organization, owning device development from early concept through commercial launch. The role requires technical depth, strong design-control and risk-management discipline, and the ability to challenge external partners, coach junior colleagues, and support regulatory interactions.
Key Responsibilities
Device Development and Engineering
  • Serve as the primary device and primary-packaging subject-matter expert across drug-product development programs from early concept through commercial launch.
  • Define and own product requirements for medical devices and drug-device combination products.
  • Recommend and defend strategies for material selection, design concepts, cost reduction, high-volume manufacturability, and process efficiency, supported by data.
  • Design, execute, interpret, and report device-development studies with emphasis on reliability testing, quality systems, and documentation rigor.
  • Develop robust devices and manufacturing and analytical processes for combination products, including injection-molded plastic components.
Design Controls, Risk, and Quality
  • Lead FMEA and FMECA risk-management activities and critically evaluate proposed technical solutions.
  • Lead and monitor Design Control documentation activities, including development of high-quality Design History Files (DHF).
  • Oversee human factors studies and related activities from planning through reporting.
  • Apply strong quality-system discipline and ensure development activities align with cGMP requirements and applicable ISO, ASTM, and ICH standards.
Cross-Functional, External, and Regulatory Leadership
  • Lead collaboration with internal teams and external development partners by setting expectations, monitoring progress against plan, and providing substantive technical challenge where needed.
  • Support Regulatory Affairs in preparing pre-registration submissions for medical devices and combination products and contribute to responses to Health Authority questions.
  • Lead or support direct interactions with regulatory bodies and relevant industry accreditation organizations.
  • Coach and develop team members and contribute meaningfully to project sub-teams, broader departmental strategy, and organizational goals.
Required Qualifications
  • Education: A relevant engineering degree at minimum (BSc or equivalent); an advanced degree in engineering or a scientific discipline (MSc or equivalent) is highly desirable.
  • Experience: At least five years in the medical device industry, with pharmaceutical development exposure strongly preferred. Hands-on experience with DPIs, MDIs, nasal sprays, and/or nebulizers is a meaningful differentiator.
  • Design and Manufacturing Depth: Demonstrated experience in product design, injection molding of plastic components, and equipment qualification. Proficiency with force-measurement and metrology tools. A background in electrical engineering or materials science is a plus.
  • Regulatory and Quality Fluency: Working knowledge of Design Control processes, cGMP requirements, and applicable ISO, ASTM, and ICH standards. Experience conducting FMEA, FMECA, and Human Factors Analysis.
  • Tools: Proficiency with SolidWorks, CAD platforms, and standard technical software environments used in medical device development.
  • Leadership: Proven ability to lead in a matrix organization by setting direction, building alignment, and developing people without relying on direct authority.
  • Communication: Strong written and verbal communication skills, including technical and scientific writing and the ability to present complex information clearly to cross-functional and regulatory audiences.
  • Work Location: Ability and willingness to work full-time on-site in the  Broward County  in South Florida. - easy access from Fort Lauderdale, Boca and Miami.  ( no state income tax ) 
Core Competencies
  • Cross-functional collaboration and stakeholder management.
  • Customer and patient centricity.
  • Developing talent and coaching others.
  • Innovation, creative problem-solving, and strategic agility in a regulated environment.
  • Process discipline, technical rigor, and result orientation.
Why This Opportunity
This is an opportunity to join a technically sophisticated R&D environment and lead device engineering across high-value drug-device combination products, with meaningful ownership from concept through commercialization and direct influence on product quality, manufacturability, regulatory readiness, and patient experience.
Compensation 
Base Salary: $110,000 – $130,000 per year (could be more for the right candidate) + full corporate benefits package, 401K, PTO and more .  Relocation assistance provided
Please apply on-line for immediate consideration. If you are match, you will be contacted by email, phone or text. Monitor your inbox, VM and spam for messages from the recruiter!!