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Validation Engineer Biomedical Jobs in Ohio (NOW HIRING)

TRIMEDX Holdings

Biomedical Technician III

Toledo, OH · On-site

Valid driver's license required; variable travel requirements depending on primary site that may ... Bachelor's degree in engineering technology preferred * Technical Certification (CBET) preferred

SIERTEK LTD

Biomedical Equipment Technician

Dayton, OH · On-site

Associate degree in Biomedical Equipment Technology or Engineering. * Minimum of two (2) years of ... Possession of a valid driver's license to operate government vehicles. * Must have a signed company ...

SIERTEK LTD

Biomedical Equipment Technician

Dayton, OH · On-site

Associate degree in Biomedical Equipment Technology or Engineering. * Minimum of two (2) years of ... Possession of a valid driver's license to operate government vehicles. * Must have a signed company ...

BESTICA INC

Biomedical Equipment technician

Houston, OH · On-site

... Engineering. * The employee shall possess at least two years of biomedical equipment technician ... The employee shall possess a valid U.S. driver's license to obtain authorization to operate a ...

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Validation Engineer Biomedical information

What does a validation engineer do in biomedical?

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.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

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 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 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 popular job titles related to Validation Engineer Biomedical jobs in Ohio?

For Validation Engineer Biomedical jobs in Ohio, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Biomedical jobs in Ohio look for?

The top searched job categories for Validation Engineer Biomedical jobs in Ohio are:

Validation Engineer Biomedical jobs near you

Biomedical Equipment Technician (BMET)

Dayton, OH • On-site

Advent Services LLC
Network Security • 11 - 50 employees
Learn more about Advent Services LLCexternal

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 9 days ago

Job description

Recruiters please do NOT contact Advent Services
A leader in supporting clients in technically demanding industries, Advent's capabilities and services promote innovation & empower our partners to manage risk, protect the information, and achieve organizational objectives. We are proud of our ability to support mission-critical systems in every phase of their lifecycle to ensure our nation's forces can accomplish their mission.
Position: Biomedical Equipment Technician (BMET)
Location: Wright Patterson AFB, OH (On-site)
Schedule: Monday-Friday, 0730-1630. Travel may be required for authorized meetings, conferences, and mission-related activities.
Mandatory Qualifications:
  • Associate's degree in Biomedical Equipment Technology, Biomedical Engineering, or a related field.
  • Minimum 2 years of Biomedical Equipment Technician (BMET) experience, including preventive maintenance, troubleshooting, repair, and system configuration management.
  • Demonstrated experience maintaining, repairing, and troubleshooting complex biomedical equipment, including hardware and software components.
  • Experience ensuring compliance with DoD, The Joint Commission, AAAHC, CAP, OSHA, NFPA, NEC, and FDA regulations and standards.
  • Ability to interpret technical drawings, schematics, blueprints, and electronic system documentation.
  • Experience troubleshooting complex electronic systems and performing signal tracing across integrated platforms.
  • Strong written, verbal, and interpersonal communication skills.
  • Valid U.S. driver's license.
  • Ability to lift equipment weighing up to 51 pounds.
  • Ability to pass a color vision test.
  • Proficiency with Microsoft Office 365, including Word, Excel, PowerPoint, Teams, SharePoint, and Adobe Acrobat.
  • Knowledge of applicable Air Force standards and regulations.
  • Ability to provide a signed Non-Disclosure Agreement (NDA) prior to the start of performance.

Highly Desired Qualifications:
  • One year of military medical or deployment experience.
  • Experience with the Defense Medical Logistics Standard Support (DMLSS) system.

Responsibilities:
  • Perform preventive maintenance, inspections, calibration, troubleshooting, repair, installation, and de-installation of biomedical equipment in accordance with OEM specifications.
  • Maintain equipment maintenance records and asset documentation within the Defense Medical Logistics Standard Support (DMLSS) system.
  • Assess equipment condition and recommend maintenance, upgrades, replacement, or disposition.
  • Inspect, diagnose, and repair malfunctioning biomedical equipment using technical manuals, schematics, and specialized test equipment.
  • Test and evaluate biomedical equipment to determine serviceability and regulatory compliance.
  • Train medical personnel on the proper operation and preventive maintenance of biomedical equipment.
  • Maintain current technical knowledge through manufacturer training and technical documentation.
  • Safely operate government vehicles to support maintenance activities at multiple facilities.
  • Follow OSHA, DoD, and medical treatment facility safety requirements, including PPE use, hazard assessments, and Lock-Out/Tag-Out (LOTO) procedures.
  • Support the Medical Readiness program by ensuring biomedical equipment remains safe, compliant, and mission ready.

Advent's benefits program includes comprehensive medical, dental and vision care, matching 401K, vacation time, sick time, life insurance, disability coverage, and other benefits that help provide financial protection for you and your family.
Advent is an Equal Opportunity Employer. Employment decisions are not based on race, color, religion, sex, national origin, disability status, genetics, protected veteran status, or any other characteristic protected by federal, state or local laws.

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