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Medical Device Validation Engineer Jobs in Florida

Arthrex

Senior Engineer I - Molding Process

Ave Maria, FL · On-site

$93K - $120K/yr

... validation of equipment and processes. * Stay current with methods used in the medical device ... Bachelor's degree in Engineering. * 5 years of manufacturing process improvement experience ...

ARTHREX

Senior Engineer I - Molding Process

Ave Maria, FL · On-site

$93K - $120K/yr

... validation of equipment and processes. * Stay current with methods used in the medical device ... Bachelor's degree in Engineering. * 5 years of manufacturing process improvement experience ...

Crown Medical, Inc.

Medical Orthopedic Rep

Ocala, FL · On-site

$50 - $70/hr

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

atrion

Quality Engineer

Davie, FL · On-site

$66K - $85K/yr

A minimum of 5 years' experience in the medical device manufacturing industry is preferred ... and validations, unit and black box testing related to safety, performance and compliance

Quality

Complaints Engineer II - TA

Sunrise, FL · Hybrid

... validation, qualification, layout, procurement, documentation, user training; support schedules ... Thorough knowledge of medical-device standards and regulations, complaint handling, Medical Device ...

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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.

Senior Engineer I - Molding Process

Arthrex

Ave Maria, FL • On-site

$93K - $120K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 14 days ago

Arthrex rating

7.8

Company rating: 7.8 out of 10

Based on 77 frontline employees who took The Breakroom Quiz

170th of 545 rated manufacturers

Job description

Requisition ID: 65816 Title:Sr. Engineer I - Molding Process
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The ideal candidate will support the Engineering Team throughout the full life-cycle development of Class I, II, and III medical devices-including both new product development and ongoing maintenance of released products. Responsibilities include designing, developing, implementing, and continuously improving manufacturing processes to ensure cost-effective, high-quality medical device production. This role will also provide manufacturing engineering expertise to create, document, and execute required procedures and technical documentation. This position is based in our Ave Maria, FL location and will work within the Molding Process Engineering Department. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties and Responsibilities:
  • Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing.
  • Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence.
  • support process improvement initiative.
  • Introduce new equipment, products, and processes. Utilizing industry standard project management tools and techniques.
  • Present process and equipment recommendations to Leadership Team with regular and timely reviews that will define team roles, responsibilities, and accountability to project plans for implementation.
  • Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
  • Develop an understanding of the current manufacturing processes and identify targets for improvement in transactional and operational efficiencies.
  • Develop manufacturing Work Instructions.
  • Provide process support on manufacturing technical issues.
  • Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies.
  • Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing.
  • Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
  • Develop protocols and coordinate validation of equipment and processes.
  • Stay current with methods used in the medical device industry to advance technologies.
  • Investigates and test in time reliability and quality improvements
  • Drives automation to replace the manual process as much as possible
  • Ensure Information and documentation is consistently accurate
  • Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
  • Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
  • Estimates production times, staffing requirements, and related costs to provide information for management decisions.
  • Applies statistical methods to estimate future manufacturing requirements and potential.
  • Provide process and equipment support.
  • Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.
  • May supervise other Engineering, Prototype or Programming personnel.

Education and Experience:
  • Bachelor's degree in Engineering.
  • 5 years of manufacturing process improvement experience required.
  • Experienced in leading process improvement projects.
  • Medical device manufacturing environment preferred.
  • Experience in workflow optimization, work measurement, efficiencies.
  • Recognized process improvement training (Lean, Six Sigma) preferred.

Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Ability to work independently and effectively with cross functional teams.
Thorough understanding of manufacturing processes.
Detail oriented with strong analytical skills.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite and CAD.
Experience with planning and conducting tests to validate equipment and processes.
Experience in completing technical documentation for engineering and manufacturing.
Familiarity with clean room practices preferred.
Project management skills preferred.
Solidworks experience preferred
C.A.M. experience preferred
Machine, Tools, and/or Equipment Skills:
Metal cutting equipment, molding, EDM, grinding equipment, finishing equipment, printing equipment, sealing equipment and custom fixturing.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate.
Arthrex Benefits
  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
Making People Better at Arthrex
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Job Details
Date: Aug 17, 2026
Requisition ID: 65816
Salary Range:
Job title: Senior Engineer I - Molding Process
Engineering
Location:

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