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Medical Device Validation Engineer Jobs in Florida

Stark Pharma Solutions Inc

Manufacturing Engineer

Orlando, FL · On-site

$68K - $87K/yr

... medical device industry. This entry-level role is ideal for recent graduates or candidates with ... Collaborate with Manufacturing, Production, Quality Assurance, Validation, Engineering, and ...

Actalent

Test Engineer

Miami, FL

Support engineering teams with product development, validation activities, and process improvement ... Prior medical device technical support experience, including troubleshooting and field or internal ...

New

Advita Ortho

Design Engineer, Packaging

Gainesville, FL · On-site

$80 - $110/hr

... medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation. Key Responsibilities * Under supervision, design and develop ...

Advita Ortho

Design Engineer, Packaging

Gainesville, FL · On-site

$122K/yr

... medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation. Key Responsibilities * Under supervision, design and develop ...

Saxon Global

QA ENGINEER

Saint Augustine, FL · On-site

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

Exactech

Design Engineer, Packaging

Gainesville, FL · On-site

$123K/yr

Design and development of medical device packaging or sterilization cases. Includes qualification ... process validation. * Under supervision, design and develop package or sterilization case ...

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Medical Device Validation Engineer information

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

What are the key skills and qualifications needed to thrive as a medical device validation engineer?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are popular job titles related to Medical Device Validation Engineer jobs in Florida?

For Medical Device Validation Engineer jobs in Florida, the most frequently searched job titles are:

What job categories do people searching Medical Device Validation Engineer jobs in Florida look for?

The top searched job categories for Medical Device Validation Engineer jobs in Florida are:

What cities in Florida are hiring for Medical Device Validation Engineer jobs?

Cities in Florida with the most Medical Device Validation Engineer job openings:

Medical Device Validation Engineer jobs near you
Infographic showing various Medical Device Validation Engineer job openings in Florida as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 12% Part Time, and 5% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Manufacturing Engineer - Medical Devices (CNC Machining Focus)

Hirekeyz Inc

Gainesville, FL • On-site

$66K - $84K/yr

Contractor

Re-posted 24 days ago

Job description

Title: Manufacturing Engineer – Medical Devices (CNC Machining Focus)

Location: Gainesville, FL (On-site)

Duration: Long Term Contract

Position Summary:

We are looking for an experienced Manufacturing Engineer with a strong background in CNC machining for precision medical device components. The candidate will be responsible for developing, optimizing, and validating CNC machining processes to meet stringent quality and regulatory requirements.


Key Responsibilities:

  • Develop, program, and optimize CNC machining processes for medical device components.
  • Select cutting tools, fixtures, and machining strategies to achieve tight tolerances and surface finish requirements.
  • Collaborate with design engineers to review drawings and ensure manufacturability.
  • Implement and maintain process controls to ensure consistent product quality.
  • Troubleshoot machining issues and implement process improvements.
  • Support process validation activities, including IQ/OQ/PQ, where applicable.
  • Maintain compliance with ISO 13485, FDA QSR, and GMP standards.
  • Train operators and technicians on CNC operation best practices.


Qualifications:

  • Bachelor’s degree in Mechanical, Manufacturing, or Industrial Engineering.
  • 6-8 years of CNC machining experience in a medical device manufacturing environment.
  • Strong knowledge of CNC programming (e.g., Mastercam, Gibbs CAM, or similar).
  • Experience with precision machining of metals, plastics, or composites used in medical devices.
  • Understanding of GD&T and blueprint reading.
  • Familiarity with regulatory requirements for medical devices.