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Validation Engineer Biomedical Jobs in Delaware (NOW HIRING)

Hologic Inc.

Product Quality Engineer 2

Newark, DE

$78K - $122K/yr

Preferred knowledge of test method validation, statistical methods, design of experiments (DOE ... Bachelor's degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Preferred knowledge of test method validation, statistical methods, design of experiments (DOE ... Bachelor's degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related ...

QPS, LLC

Mass Spectrometry Technician

Newark, DE · On-site

$48K - $52K/yr

Are you a recent Biomedical, Electronic, or Electrical Engineering graduate who enjoys working ... Support equipment validation and system performance verification * Install and configure new ...

Christiana Care Health Services

$85K - $137K/yr

Perform structured validation (unit, integration, regression, and UAT testing) for all upgrades ... Biomedical Engineering, or related field (or equivalent experience). * 4+ years of experience ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Delaware

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
Manufacturing Quality Engineer - Newark, DE

Manufacturing Quality Engineer - Newark, DE

Fusion Life Sciences

Newark, DE • On-site

$72K - $93K/yr

Contractor

Re-posted 18 days ago

Job description

Title : Manufacturing Quality Engineer
Location : Newark, DE
Long-term contract
 
Overview

We are partnering with a leading medical device organization to build out a high-impact engineering team supporting their flagship mammography systems. This is a critical initiative focused on strengthening the foundation of their Quality Management System and driving validation excellence across manufacturing operations. 

Must-Have Background

  • 4–5+ years medical device experience (minimum)
  • Engineering degree required (Mechanical, Biomedical, Industrial, etc.)
  • Experience at established med device companies (e.g., Stryker, J&J, etc.)
  • Prior remediation experience strongly preferred
  • Strong validation and TMV experience 

Day to Day

  • Review and enhance existing PFMEAs, Identify missing failure modes and risk gaps, strengthen mitigations and ensure appropriate controls are in place (PFMEA assessment, development, and remediation). 
  • Conduct thorough process risk analysis, drive root cause investigations and implement corrective actions.
  • Lead and execute validation activities (IQ/OQ/PQ), develop and defend validation strategy and protocols, execute and document TMV activities
  • Manage deviations, link risks appropriately, and ensure regulatory alignment
  • Collaborate cross-functionally with manufacturing, quality, and program management stakeholders