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Medical Device Validation Engineer Jobs in New Port Richey, FL

Quality Assurance Engineer

Tampa, FL ยท On-site

$25 - $35/hr

Quality Assurance Engineer Location: Tampa, FL - 33634 Duration: 12 months Job Type: Temporary ... validation (CSV). * Experience in biologics, pharmaceutical, or medical device manufacturing ...

Biomedical Engineering Tutor

Tampa, FL ยท Remote

$18 - $40/hr

Ability to explain signal processing for biosignals, finite element analysis, drug delivery systems, and medical device design principles while preparing students for biomedical engineering ...

Cardiac Device Technician

Largo, FL ยท On-site

$16.75 - $21.25/hr

Comprehensive medical coverage that covers many common services at no cost or for a low copay ... Provide thorough, proficient pacemaker and AICD interrogation and re-programming cardiac device ...

Assembler

Oldsmar, FL ยท On-site

$24/hr

Work closely with Engineering, Quality, and Manufacturing teams to refine processes and reduce ... Familiarity with aerospace (AS9100) or medical device (ISO-13485) quality management systems.

Sr. Analytics Engineer

Tampa, FL

$98K - $135K/yr

Relevant medical device or biopharma experience a plus. Responsibilities of the Sr. Analytics Engineer The specific duties of the Sr. Analytics Engineer include but are not limited to: Semantic Model ...

Sr. Analytics Engineer

Tampa, FL ยท On-site

$98K - $135K/yr

Relevant medical device or biopharma experience a plus. Responsibilities of the Sr. Analytics Engineer The specific duties of the Sr. Analytics Engineer include but are not limited to: Semantic Model ...

Sr. Analytics Engineer

Tampa, FL ยท On-site

$98K - $135K/yr

Relevant medical device or biopharma experience a plus. Responsibilities of the Sr. Analytics Engineer The specific duties of the Sr. Analytics Engineer include but are not limited to: Semantic Model ...

Showing results 21-40

Medical Device Validation Engineer information

See New Port Richey, FL salary details

$20

$46

$69

How much do medical device validation engineer jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for medical device validation engineer in New Port Richey, FL is $46.31, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $56.30 per hour, depending on experience, location, and employer.

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 cities near New Port Richey, FL are hiring for Medical Device Validation Engineer jobs?

Cities near New Port Richey, FL with the most Medical Device Validation Engineer job openings:

Patient Specialist - Tampa, FL (1099 Contractor, Per Diem/On Call)

Kestra Medical Technologies Inc.

Tampa, FL โ€ข On-site

Per diem

Posted 3 days ago

New


Job description

The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra's solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life.
The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra's solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life.
The ASSURE Patient Specialist (APS) conducts patient fitting activities in support of the sales organization and the team of Regional Clinical Advisors (RCA). The APS will serve as the local patient care representative to provide effective and efficient patient fittings.
We have an opening in Tampa, FL.
This is a paid per fitting position.
ESSENTIAL DUTIES
  • Act as a contractor ASSUREยฎ Patient Specialist (APS) to fit and train local patients with a wearable defibrillator via training assignments dispatched from corporate headquarters. The APS will be trained and Certified as an ASSURE Patient Specialist by Kestra.
  • Ability to provide instruction and instill confidence in Assureยฎ patients with demonstrated patient care skills
  • Willingness to contact prescribers, caregivers and patients to schedule services
  • Ability to accept an assignment that could include daytime, evening, and weekend hours
  • Travel to hospitals, patient's homes and other healthcare facilities to provide fitting services
  • Measure the patient to determine the correct garment size
  • Review and transmit essential paperwork with the patient to receive the Assureยฎ garment and services
  • Manage inventory of the Assureยฎ system kits, garments, and electronic equipment used in fittings
  • Flexibility of work schedule and competitive pay provided
  • Adhere to Pledge of Confidentiality
    • Information regarding a patient of this company shall not be released to any source outside of this company without the signed permission of the patient. Furthermore, information will only be released internally on a need-to-know basis. All Team Members will not discuss patient cases outside the office or with anyone not employed by this company unless they are directly involved with the patient's case

COMPETENCIES
  • Passion: Contagious excitement about the company - sense of urgency. Commitment to continuous improvement.
  • Integrity: Commitment, accountability, and dedication to the highest ethical standards.
  • Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service.
  • Action/Results: High energy, decisive planning, timely execution.
  • Innovation: Generation of new ideas from original thinking.
  • Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind.
  • Emotional Intelligence: Recognizes, understands, manages one's own emotions and is able to influence others. A critical skill for pressure situations.
  • Highly organized, service and detail orientated
  • Passionate about the heart-failure space and a strong desire to make a difference
  • Strong interpersonal skills with communicating and assisting clinicians with providing care for patients.
  • Interest and desire for life-long learning to continuously improve over time.

REQUIREMENTS:
Education/Experience Required:
  • 1 year in a paid patient care experience (not as a family care giver)
  • Clinical or engineering background which may include but is not limited to nurses, cardiac device sales representatives, clinical engineers, catheterization lab technicians, physician assistants, or ECG technicians.
  • Disclosure of personal NPI number (if applicable)
  • Completion of background check. Florida and Ohio must complete a level 2 screening paid for by Kestra.
  • Willingness to pay an annual DME fee which is deducted from the completed work order
  • Ability to pay for vendor credentialing upfront during a 90-day probationary period
  • Experience in patient and/or clinician education
  • Valid driver's license in state of residence with a good driving record
  • Ability to consistently work in the field in and around the region. Disclosures are required for any potential relationships and referral sources
  • Must be able to achieve credentialing for hospital system entry including, but not limited to:
    • Documentation of vaccination and immunization status
    • Pass background check
    • Pass drug screening testing
    • Review and agree to hospital policies and procedures
    • Completion of online courses, i.e., HIPAA, Bloodborne Pathogens and Electrical/Fire Safety

Preferred:
  • Knowledge of MS Office, Excel, PowerPoint, MS Teams
  • Direct cardiac patient care experience - RN, RT, CVIS, Paramedic, CRM

WORK ENVIRONMENT
  • Variable conditions during travel
  • Minimal noise volume typical to an office or hospital environment
  • Possible environmental exposure to infectious disease (hospital and clinic settings)
  • Extended hours when needed
  • Drug-free

PHYSICAL DEMANDS
  • Ability to travel by car
  • Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
  • Frequent stationary position, often standing or sitting for prolonged periods of time
  • Frequent computer use
  • Frequent phone and other business machine use
  • Occasional bending and stooping
  • Ability to lift up to 40 pounds unassisted, at times from in and out of vehicle

TRAVEL
  • Frequent travel by car in agreed upon geography

OTHER DUTIES:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
Kestra Medical Technologies, Inc does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.