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Medical Device Validation Engineer Jobs in Florida

VIVEX Biologics, Inc.

Validation Engineer II

Miami, FL · On-site

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

VIVEX BIOLOGICS INC

Validation Engineer II

Miami, FL · On-site

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

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 ...

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

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;

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;

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 · On-site

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 July 2026, with employment types broken down into 77% Full Time, 16% Part Time, and 7% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Validation Engineer II

VIVEX Biologics, Inc.

Miami, FL • On-site

Full-time

Re-posted 11 days ago

Job description

The Validation Engineer II ensures the reliability, consistency, and compliance of our processes, equipment, and systems to meet regulatory requirements and quality standards. This role mainly drives the preparation and execution of validation documentation, including User Requirements Specifications, Installation, Operational and Performance Qualification Protocols and Validation Summary Reports. This includes leading and/or supporting validation of processes, equipment, and computer systems. The Validation Engineer II also provides assistance to system owners with impact risk assessments to identify the qualification and validation requirements, carrying out validation activities on equipment before returning or handing over to the system owner, and assist in arranging external services when required.
Requirements
Duties and responsibilities
  • Perform critical review of Validation Engineer I project plans and related documents to ensure implementation is accurate and timely.
  • Independently lead and coordinate cross-functional projects and related resources to ensure completion in a timely manner. Communicate to management of performance against project plan.
  • Perform data and technical presentation reviews as needed.
  • Lead specific tasks or larger projects and ensure their successful completion, with minimal oversight.
  • Develop and execute validation plans for both new and existing processes, equipment, and systems.
  • Generate and execute qualification protocols to perform equipment qualifications and process validations. This includes establishing performance criteria, equipment troubleshooting, and ensuring compliance with safety and quality standards.
  • Support company's Master Validation Plan (MVP) including commissioning activities and protocols executions and establishing re-validation criteria.
  • Collaborate with cross-functional teams to provide validation-related guidance, solve technical problems, and contribute to project milestones.
  • Assess the impact of process, material, or equipment changes on validation status and provide guidance on revalidation or change control measures.
  • Identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively.
  • Train personnel involved in validation activities and offer expertise and support to other departments on validation-related matters.
  • Ensure personal and company compliance with all federal, state, company and regulatory bodies' regulations, policies, and procedures.
  • Other duties as assigned.
Qualifications
  • Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred.
  • At least 2-5 years of experience in related Engineering role. Experience in validations preferred.
  • Strong knowledge of FDA, AATB, and cGTP guidelines preferred.
  • Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
  • Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs) preferred.
  • Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
  • Effective oral, written, communication, and presentation skills.
  • Strong analytical and problem-solving skills.
  • Project management skills preferred.
  • Ability to be assertive and influence others and lead significant change.
Working conditions Job requires working in-office, must be willing to work weekends and evening hours, as necessary. Must be willing to accommodate travel, as necessary. Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards. Physical requirements While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
Disclaimer: Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship.
Direct reports No direct reports (Individual contributor role) Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training. Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.

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