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USA - Systems Engineer III - CTQ
Baxter Parkway Riverwoods, IL 60015 US
Job Description
Target Pay Rate: 50-60/hr **salary will be commensurate with experience
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:
- Bachelors or Masters 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).
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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