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Medical Device Validation Engineer Jobs in Florida

VIVEX BIOLOGICS INC

Validation Engineer II

Miami, FL · On-site

Description The Validation Engineer II ensures the reliability, consistency, and compliance of our ... Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry. * Experience ...

Alleima

Validation Engineer

Palm Coast, FL · On-site

... such as medical device, pharmaceutical, biotechnology, or a comparable industry. You have ... Engineering, Life Sciences, or a related technical discipline such as Mechanical, Chemical ...

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 ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Crown Medical, Inc.

Medical Device Rep

Sarasota, FL · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Building Block Co

FL · On-site

Foot and Ankle Medical Device Sales Representative Position Overview: Are you thrilled by the ... A valid driver's license and vehicle to ensure your mobility and readiness to serve our clients.

Stem Xpert

GW/Routers Validation Engineer

Tampa, FL

DOCSIS 3.0 and VoIP, SIP, MGCP applications testing using a CPE device Review product requirements ... Design, write and execute test plans to validate VoIP application functionality. Own and maintain ...

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 ...

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Medical Device Validation Engineer information

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 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.

Are medical device validation engineers in demand?

Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.

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 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 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 61% Full Time, 6% Temporary, and 33% Contract. Highlights an 94% In-person, and 6% Remote job distribution.

Senior Quality Engineer, Validation

Exactech

Gainesville, FL

$80K - $108K/yr

Full-time

Posted yesterday

New

Exactech rating

8.0

Company rating: 8.0 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description


This position offers flexibility to align with the candidate's experience level and can be structure as a Senior Validation Engineer role for those with advanced expertise.  

The Validation Engineer provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Validation Engineer is results oriented and has the knowledge and confidence in the areas of Quality Assurance and validation/verification (V&V). 
  • Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports. 
  • Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies. 
  • Leads or participates in the validation of corporate software packages ensuring adherence to industry requirements. 
  • Use statistical techniques, as necessary, to properly design and execute V&V activities. 
  • Prepare documentation and execute V&V activities utilizing a risk based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations. 
  • Coordinate personnel training, protocol and process documentation/record retrieval, as necessary, supporting timely execution and closure of all corporate V&V activities.  
  • Maintain corporate validation process auditing program ensuring timely completion of auditing activities. 
  • Maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings. 
  • Lead the identification, maintenance, development and enhancement of corporate systems, processes and standards. 
  • Identify, analyze and correct internal and external manufacturing deviations and/or anomalies related to V&V activities ensuring optimization of production processes. 
  • Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation. 
  • Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase. 
  • Informs Regulatory Affairs of validation projects that may require further reporting/scrutiny (e.g. PMA devices). 
  • Participate in the review and qualification of external supply chain V&V activities. 
  • Take primary responsibility for company-wide validation related Corrective and Preventive Actions that may result from internal/external non-conformances, recalls and/or field actions. 
  • Define and lead third party, customer and regulatory audits as they pertain to validations. 
Education:
  • Bachelor's Degree from an accredited institution required; Master's Degree preferred  
 Experience:
  • Advanced level of technical software proficiency 
  • Excellent Quality System knowledge required 
  • Strong time management and project management skills are necessary. 
  • Experience writing IQ/OQ/PQ V&V protocols. 
  • Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.  
  • General understanding of sterilization and related analytical testing is a plus. 
    Must be able to work independently and in a team environment.  
Functional/Technical Knowledge, Skills and Abilities Required:
  • Statistical expertise in areas such as process capability, process assurance and sampling 
  • Expertise in Microsoft Office products 
  • Ability to work effectively in a team environment 
  • ASQ Certifications preferred 
  • Advanced level of technical software proficiency 
  • Working knowledge of statistical analysis and sampling plans. 
  • Excellent communication (written and verbal) skills. 
  • Excellent organization skills. 

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