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Validation Engineer Biomedical Jobs in Tennessee

Sapsol Technologies Inc

Program Engineer

Nashville, TN · On-site

... and validation of oscillating gradient diffusion (OGSE/OGD) MRI methods in partnership with ... B.S. or M.S. in Electrical Engineering, Biomedical Engineering, Physics, Computer Science, or ...

Smiths Machine

Manufacturing Engineering {SE}

Bartlett, TN

$65K - $83K/yr

Testing and Validation: Perform detailed analysis and testing to validate product performance and ... Bachelor's degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a ...

Sapsol Technologies Inc

Medical Engineer

Nashville, TN · On-site

This role supports the development, integration, and validation of advanced MRI methods across two ... Master's or PhD in MRI Physics, Biomedical Engineering, Medical Physics, Electrical Engineering ...

Sapsol Technologies Inc

Medical Engineer

Nashville, TN · On-site

This role supports the development, integration, and validation of advanced MRI methods across two ... Master's or PhD in MRI Physics, Biomedical Engineering, Medical Physics, Electrical Engineering ...

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Validation Engineer Biomedical information

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are some typical challenges faced by Validation Engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What are the key skills and qualifications needed to thrive as a Validation Engineer in Biomedical, and why are they important?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What does a Validation Engineer do in the biomedical field?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.
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Validation Engineer Biomedical jobs near you
Biomedical Equipment Technician II

Biomedical Equipment Technician II

TRIMEDX Holdings

Murfreesboro, TN • On-site

Full-time

Posted yesterday

Trimedx rating

7.9

Company rating: 7.9 out of 10

Based on 80 frontline employees who took The Breakroom Quiz

65th of 238 rated repair and maintenance companies

Job description

If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance.

  • Everyone is focused on serving the customer and we do that by collaborating and supporting each other
  • Associates look forward to coming to work each day
  • Every associate matters and makes a difference

It is truly a culture like no other - We hope you will join our team! Find out more about our company and culture here.

Summary

The Biomedical Technician II (BMET II) is required to install, inspect, troubleshoot, repair, calibrate, and verify the performance of complex biomedical equipment with minimal supervision. The individual should be competent in the use of all applicable test equipment and tools required in the performance of these duties. The BMET II may serve as technical advisor to the medical and clinical staff in the safe operation and use of clinical equipment. This position also assists in developing specifications for the selection of new clinical equipment. The individual demonstrates adherence to the TriMedx core values in all professional interactions by showing respect to all people, creating real value, initiating meaningful change, and exhibiting integrity.

Responsibilities

Technical Service - 40%

  • Perform performance assurance (PA) inspections, scheduled maintenance, electrical safety inspections (ESI), and operation verification procedures (OVP) on complex and intricate biomedical equipment

  • Repair, install, and calibrate complex and intricate biomedical equipment

  • Inform supervisors of the status of repairs, scheduled inspections, unusual equipment situations, and any customer concerns

  • Work with, direct, and document the activities of subcontractors, vendors, and outside service technicians to ensure proper service delivery

  • Maintain biomedical expertise through ongoing training and education

  • Assist with Service Operations Special Projects as assigned

Regulatory Compliance - 25%

  • Ensure the accuracy and integrity of the equipment database to include the inventory, performance assurance (PA) schedules, nomenclature, and service history

  • Adheres to the Medical Equipment Management Plan (MEMP), including all regulatory agency compliances and other applicable policies and procedures

  • Responsible for ensuring all service and documentation is complete, timely, and accurate

Account Relationship Management - 25%

  • Build and maintain customer relationships

  • Discuss equipment status and functionality with clinicians

  • Adheres to the Mission, Vision, and Values of the organization(s) served.

  • Provide a positive representation of TriMedx services by integrating the core values into job performance

Inventory - 10 %

  • Perform periodic inspections of current inventory status

  • Verify the completion of security analysis for new customer equipment

  • Performs Incoming Inspections (II) to maintain a complete and accurate inventory of medical devices, including trial and evaluation, rental, and loaner equipment in addition to permanently assigned equipment inventory.

  • Maintain the accuracy and integrity of the equipment database to include inventory, performance assurance (PA) schedules, nomenclature, and service history

  • Make recommendations regarding inventory

All other duties as assigned

Skills and Experience

  • Complex computer skills including the ability to administrate a system, interpret error codes, defragment hard-drives, replace power supplies, and interpret computer codes required

  • Ability to integrate information from a variety of sources

  • Excellent interpersonal and customer service skills

  • Strong written, verbal, and presentational communication skills

  • Valid driver's license required; variable travel requirements depending on primary site that may require use of personal vehicle

Education and Qualifications

  • 2 year degree in a technical/electronics field or equivalent experience required. This requirement will be waived if the applicant has received the TRIMEDX Trained Certification or completed an equivalent biomedical related certification program.

  • Technical Certification (CBET) strongly preferred

  • Minimum 3 years' experience working with biomedical equipment in a clinical engineering environment

  • Travel may be required based on customer or business needs

At TRIMEDX, we are committed to cultivating a workplace culture where every associate feels valued, supported, and empowered to thrive. This culture reflects our belief that our people are our foundation, their well-being is essential, and shared success is built through meaningful work, recognition, and opportunities for growth.

We embrace people's differences which include age, race, color, ethnicity, gender, gender identity, sexual orientation, national origin, education, genetics, veteran status, disability, religion, beliefs, opinions and life experiences.

Visit our website to view our Workplace Culture Commitment , along with our social channels to see what our team is up to: Facebook, LinkedIn, Twitter.

TRIMEDX is an Equal Opportunity Employer. Drug-Free Workplace.

Because we are committed to providing a safe and productive work environment, TRIMEDX is a drug-free workplace. Accordingly, Associates are prohibited from engaging in the unlawful manufacture, sale, distribution, dispensation, possession, or use of any controlled substance or marijuana, or otherwise being under the influence thereof, on all TRIMEDX and Customer property or during working/on-call hours.

What Trimedx employees say

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About TRIMEDX

Sourced by ZipRecruiter

Founded in the summer of 1998, TRIMEDX was the solution to one technician's vision of how to operate a hospital medical equipment service center of excellence. Today, TRIMEDX is the largest independent medical equipment service provider with locations in over 40 states and 3,000+ employees. We share in a common purpose of serving customers, patients, communities and each other with equal measures of caring and performance.

Industry

Health care and social assistance

Company size

1,001 - 5,000 Employees

Headquarters location

Indianapolis, IN, US

Year founded

1998

Social media

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