Performance Test Engineer( software/hardware testing/Medical product)

Description:

Reliability Performance Engineer
Hybrid in Deerfield

8 months contract ; May extend ;

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 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 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).

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