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Validation Engineer Biomedical Jobs in Illinois (NOW HIRING)

Bannerhealth

Biomedical IoMT Specialist

Banner, IL · On-site

Must have 5 years of experience in IT, Biomedical Engineering, and/or Cybersecurity within a health ... Must possess a valid driver's license and be eligible for coverage under the company auto insurance ...

Bannerhealth

Biomedical IoMT Specialist

Banner, IL · On-site

Must have 5 years of experience in IT, Biomedical Engineering, and/or Cybersecurity within a health ... Must possess a valid driver's license and be eligible for coverage under the company auto insurance ...

UWHealth

Biomedical Technician

Rockford, IL

$25.25 - $33.50/hr

Associate's degree in Electronics, Biomedical Engineering, or related field. Two (2) years of ... Must have valid driver's license and must have a driving record that allows for the Health System ...

UW Health

Biomedical Technician

Rockford, IL · On-site

$27.74 - $40.23/hr

Associate's degree in Electronics, Biomedical Engineering, or related field. Two (2) years of ... Must have valid driver's license and must have a driving record that allows for the Health System ...

Agiliti

Biomedical Equipment Technician

Chicago, IL

$25.79 - $41.27/hr

An associate degree in electronics, mechanical engineering, or biomedical equipment technology ... Must hold a current, valid, and unrestricted driver's license. Must have a safe driving record ...

Stark Pharma Solutions Inc

Manufacturing Engineer

Lakewood, IL · On-site

$70K - $91K/yr

... Biomedical Engineering, or related field. * 2-5 years of manufacturing engineering experience within the medical device or regulated industry. * Experience with process validation (IQ/OQ/PQ), GMP ...

Agiliti

Biomedical Equipment Technicain

Chicago, IL · On-site

$25.79 - $41.27/hr

An associate degree in electronics, mechanical engineering, or biomedical equipment technology ... Must hold a current, valid, and unrestricted driver's license. Must have a safe driving record ...

Mercyhealth

Biomedical Equipment Technician

Freeport, IL · On-site

$25.60 - $38.40/hr

Associate Degree in Bio-Medical Engineering/Electronics or related degree or Military Bio-Medical ... Maintain a valid driver's license. * Have and maintain an acceptable driving record per Mercyhealth ...

Mercyhealth

Biomedical Equipment Technician

Freeport, IL

$25.60 - $38.40/hr

Associate Degree in Bio-Medical Engineering/Electronics or related degree or Military Bio-Medical ... Maintain a valid driver's license. * Have and maintain an acceptable driving record per Mercyhealth ...

Trimedx

Biomedical Technician II

Rockford, IL · On-site

$27 - $31/hr

Valid driver's license required; variable travel requirements depending on primary site that may ... Minimum 3 years' experience working with biomedical equipment in a clinical engineering environment

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Illinois

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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What job categories do people searching Validation Engineer Biomedical jobs in Illinois look for? The top searched job categories for Validation Engineer Biomedical jobs in Illinois are:
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Validation Engineer Biomedical jobs near you

Reliability & Validation Engineer (Medical Devices) - Hybrid

DivIHN Integration Inc

Deerfield, IL • On-site

Other

Re-posted 15 days ago

Job description

For further inquiries regarding the following opportunity, please contact our Talent Specialist
Kunal at 224-704-1709

Title: Reliability & Validation Engineer (Medical Devices) - Hybrid
Location: Deerfield, IL
Duration: 10 Months
Description:
Job Summary
We are seeking a Reliability Performance Engineer to develop and execute testing documentation and scripts that validate and verify both physical and digital Client's medical products. This role will be responsible for designing, implementing, and managing test protocols that ensure product reliability, security, and performance under various conditions, including high-volume simulations, network interactions, and cybersecurity challenges. The ideal candidate has a strong background in test automation, system validation, and compliance-driven testing within the medical device industry.
Key Responsibilities
Test Development & Execution
Create detailed test plans, scripts, and protocols to validate software, firmware, and hardware components of Client's medical devices.
Develop and automate tests that simulate high-volume data processing, real-world network interactions, and security threats.
Conduct functional, integration, and system-level testing to ensure compliance with regulatory and industry standards.
Perform manual and automated testing for both digital (software-based) and physical (hardware-based) products.
Simulation & Performance Testing
Design and execute high-volume simulations to evaluate device performance under extreme workloads.
Validate network reliability by simulating real-world connectivity scenarios, including cloud, IoT, and hospital network environments.
Conduct cybersecurity testing, including penetration testing, encryption validation, and threat modeling.
Data Analysis & Reporting
Analyze test results, identify failure points, and collaborate with R&D, engineering, and security teams for issue resolution.
Document testing methodologies, defects, and performance metrics in compliance with FDA, ISO 13485, IEC 62304, and HIPAA regulations.
Support root cause analysis (RCA) and corrective/preventive actions (CAPA) based on test findings.
Collaboration & Continuous Improvement
Work closely with software developers, network engineers, and product designers to refine product testing approaches.
Develop and maintain automated test frameworks for continuous integration/continuous deployment (CI/CD).
Stay updated on medical device regulations, cybersecurity best practices, and emerging testing technologies.
Qualifications & Skills
Required:
Bachelor's or Master's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field.
years of experience in software/hardware testing, automation, or medical device validation.
Strong knowledge of test scripting languages (Python, Java, C#, or similar).
Experience with test management tools (e.g., TestRail, JIRA, Selenium, Appium, Cypress).
Familiarity with network protocols, security testing, and performance benchmarking.
Understanding of FDA 21 CFR Part 820, ISO 14971 (Risk Management), and IEC 60601 standards.
Preferred:
Experience with cloud-based medical device testing (AWS, Azure, IoT platforms).
Knowledge of cybersecurity frameworks (NIST, OWASP, FIPS 140-2).
Certification in ISTQB, CISSP, or Certified Ethical Hacker (CEH).

About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.