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Validation Engineer Biomedical Jobs in Tennessee

TriMedx

Biomedical Engineering Apprentice

Nashville, TN · On-site

$24.50 - $32.25/hr

Understand the typical day of an engineer and how to work in a hospital environment * Respond to ... Valid driver's license required; variable travel requirements depending on primary site or region ...

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?

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 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.
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Validation Engineer Biomedical jobs near you

Mechanical or Biomedical Engineer - Product Design & Development

Enexor

Franklin, TN • On-site

Full-time

Medical, Retirement, PTO

Re-posted 28 days ago

Job description

About Us

We are an early-stage company developing disruptive medical technologies that challenge industry norms and dramatically reduce cost and complexity. Our small, hands-on team designs, builds, and validates next-generation medical devices entirely in-house from concept through FDA submission.

If you are motivated by hard problems, rapid iteration, and real-world impact, this is the kind of place where your work will matter every day.

The Opportunity

We have openings for Mechanical or Biomedical Engineers who are either recent graduates or have up to five years of professional experience. You will help design and develop a new Class II medical device from the ground up and be involved in every part of the process, including CAD modeling, prototyping, system integration, and verification and validation (V&V).

What You Will Do
  • Design and model mechanical subsystems and assemblies using Autodesk Inventor
  • Build and test prototypes for airflow, pressure, vibration, and structural performance
  • Support DFM, BOM creation, and documentation under FDA design control
  • Participate in bench and environmental testing for verification and validation
  • Collaborate with electrical, firmware, and manufacturing teams to integrate systems
  • Contribute to risk analysis, labeling, and regulatory documentation

Requirements

What We Are Looking For
  • B.S. or M.S. in Mechanical or Biomedical Engineering
  • Strong fundamentals in fluid dynamics, pressure systems, and mechanical design
  • Hands-on experience with prototyping or lab testing
  • Curious, adaptable, and motivated to learn in a fast-paced, collaborative environment
Preferred Experience
  • Up to five years of experience in product design or medical device development
  • Familiarity with ISO 13485, IEC 60601, or FDA 510(k) processes
  • Experience in machining, additive manufacturing, or test fixture design

Benefits

What We Offer
  • Competitive salary and equity opportunity
  • Health insurance stipend (QSEHRA) and 401(k)
  • Paid vacation and holidays
  • A front row seat in a fast-growing, mission-driven medtech startup

Apply