What are the responsibilities and job description for the Reliability & Validation Engineer (Medical Devices) - Hybrid position at DivIHN Integration Inc.?
Job Details
DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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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.
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.
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).
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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
