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Medical Device Risk Management Jobs in Florida (NOW HIRING)

Under the supervision of the Director of Risk Management / Performance Improvement provides ... Medical, Dental, Vision, EAP, and Prescription Drug Plan · 401k plan with company match · ...

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Medical Device Risk Management information

See Florida salary details

$38.5K

$83.4K

$127K

How much do medical device risk management jobs pay per year?

As of Jul 5, 2026, the average yearly pay for medical device risk management in Florida is $83,365.00, according to ZipRecruiter salary data. Most workers in this role earn between $67,300.00 and $96,400.00 per year, depending on experience, location, and employer.

Is risk management a good career?

Risk management in the medical device industry involves identifying and mitigating potential safety and compliance issues, which is essential for product development and regulatory approval. It requires strong analytical skills, knowledge of standards like ISO 14971, and often involves collaboration with engineering and quality teams. The field offers opportunities for growth, specialization, and a stable career path due to the importance of safety in healthcare products.

What is the highest paying risk management job?

In the field of medical device risk management, senior roles such as Risk Management Directors or Chief Risk Officers typically have the highest salaries, often exceeding six figures. These positions require extensive experience, certifications like ISO 14971, and leadership skills, reflecting their strategic importance and responsibility within organizations.

How much does a risk manager get paid?

A medical device risk management professional's salary typically ranges from $70,000 to $130,000 annually, depending on experience, certifications, and location. Senior risk managers or those with specialized skills can earn higher salaries, especially in regulated environments requiring knowledge of ISO 14971 and risk assessment tools.

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 risk management in the medical device industry?

Risk management in medical device risk management involves identifying, assessing, and controlling potential hazards associated with medical devices to ensure patient safety and regulatory compliance. Professionals in this field use tools like risk analysis and failure mode effects analysis (FMEA) and often require knowledge of standards such as ISO 14971. Effective risk management is essential throughout the device lifecycle, from design to post-market surveillance.

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 popular job titles related to Medical Device Risk Management jobs in Florida? For Medical Device Risk Management jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Medical Device Risk Management jobs in Florida look for? The top searched job categories for Medical Device Risk Management jobs in Florida are:
What cities in Florida are hiring for Medical Device Risk Management jobs? Cities in Florida with the most Medical Device Risk Management job openings:
Senior Engineer I, Device Development

Senior Engineer I, Device Development

Alexion Pharmaceuticals

Daytona Beach, FL • On-site

$97K - $146K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 19 days ago


Job description

Location: Boston, MA or New Haven, CT

This is what you will do:
This position will serve the role of Development Engineer within the Alexion Device Development organization.
The candidate will act as the technical SME/project engineer supporting the development of combination products.
This role will be accountable for key technical design and development deliverables.
This individual will interact with multiple functions and functional teams including Device Quality, Regulatory Affairs, Clinical, Global Technical Operations (GTO), and Alexion Dublin Manufacturing Facility (ADMF) from clinical development through commercial development.
You will be responsible for:
Deep understanding of the device design: this may include development/ identification of critical dimensions, systems engineering, sensitivity analysis, tolerance stack-ups.

Technical assessments to be conducted via analytical and empirical means.

Devices of interest include: pre-filled syringes, autoinjectors, pen injectors, and on-body delivery systems.

Based on understanding of device design, manage facets of technical development. This can include interactions with suppliers, CMOs, technology vendors and/or internal cross-functional teams.

Oversee the characterization and design verification testing as well as determine relevant success criteria. This includes development, qualification, and the transfer of the appropriate methods.

Author technical documentation in support of the development process or design control deliverables.

Root Cause analysis of product or process deviations or failures. Utilization of six sigma tools to manage the investigation.

Ability to clearly communicate learnings and educate other team members on methods and analytical approaches.

Acts independently within team expectations, coordinates with functional leadership to identify priorities, completes tasks under his/her accountability while balancing a high level of autonomy .

Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation.

Demonstrate strong and clear accountability/responsibility for successful and timely completion of designated tasks.
You will need to have:
BS Degree (Mechanical, Biomedical, Chemical Engineering or Materials Science and Engineering)or closely related disciplines

6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries or related experience (experience with combination products, specifically prefilled syringes, autoinjectors, pen injectors, and on-body injectors preferred).

Experience with developing products or implementing product changes through a structured, phase-gated, product development process.

Demonstrated experience with all phases of the Design Control process.
Demonstrated experience in a technical, product development role on a cross-functional team, leadership role preferred.

Understanding of medical device product development risk management methodologies.

Possesses expertise in statistical analysis (Minitab, Crystal Ball, etc), analytical tools (e.g. FEA), benchtop testing (e.g. Zwick, fixture design) and experience in root cause analysis/investigation

Strong team building and collaboration skills across the organization. Possesses intellectual curiosity to deeply understand technical concepts.

Knowledge of performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements).

The duties of this role are generally conducted in an office environment.As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Master's, or PhD Degree in Engineering(Mechanical, Biomedical, Chemical or Materials Science and Engineering)or closely related disciplines preferred.

6-10+ years of experience inmedical device/container closure development with 2+ years in combination product commercialization.

The annual base salary for this position ranges from $97,000 to $146,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

08-Jun-2026

Closing Date

09-Jul-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.