Lake, Illinois
Job Summary
As a part of the Design Validation Team, the Registered Nurse (RN) is a key stakeholder of device design and development team. In this role The RN is responsible for providing clinical expertise to support the design validation of infusion pump systems. This role ensures that products are safe, effective, and meet user needs by participating in human factors evaluations, simulated-use testing, and clinical workflow validation activities.
The RN collaborates cross-functionally with engineering, human factors, quality, regulatory, and clinical teams to represent the voice of the end user throughout product development.
Key Responsibilities
Clinical Expertise & User Representation
Serve as a clinical subject matter expert (SME) for infusion therapy practices, workflows, and patient safety considerations
Translate real-world clinical use into design input and validation requirements
Ensure device usability aligns with nursing workflows and standards of care
Design Validation Activities
Plan, develop, and execute design validation studies, including simulated-use and usability testing
Participate in formative and summative human factors evaluations
Support protocol development, test execution, and data collection
Evaluate whether product design meets intended use and user needs
Testing & Simulation
Conduct hands-on testing of infusion pump systems in simulated and controlled environments
Identify use-related risks, potential errors, and opportunities for design improvement
Provide detailed observations and documentation of user interactions with devices
Documentation & Compliance
Author and review validation protocols, reports, and test documentation in accordance with regulatory standards (FDA, ISO 13485, IEC 62366, etc.)
Ensure compliance with design control requirements and quality system procedures
Support audit readiness and regulatory submissions as needed
Cross-Functional Collaboration
Partner with engineering, quality, risk management, and human factors teams
Contribute to risk analyses (e.g., use-related risk assessments, FMEA)
Provide input to design reviews and development milestones
Training & Support
Assist in development of training materials, instructions for use (IFU), and labeling
Support internal teams by educating on clinical workflows and infusion therapy practices
Skill Requirements
Required Qualifications
Active Registered Nurse (RN) license in good standing
Bachelor of Science in Nursing (BSN) required
Minimum 3–5 years of clinical nursing experience, preferably in areas involving infusion therapy (e.g., ICU, oncology, med-surg, home infusion)
Strong understanding of infusion pumps, IV therapy, and medication administration
Preferred Qualifications
ICU,NICU,PICU experience is preferred
Experience in medical device development, design validation, or human factors engineering
Experience conducting usability studies or simulated-use testing
Certified Infusion Nurse (CRNI) or similar certification
Other Requirements
Key Skills & Competencies
Strong clinical judgment and attention to patient safety
Analytical thinking and problem-solving skills
Excellent written and verbal communication
Ability to document findings clearly and objectively
Detail-oriented with strong organizational skills
Ability to work effectively in cross-functional teams
Work Environment
Combination of office, lab, and simulated clinical environments
May require participation in simulated clinical scenarios and usability labs
Occasional travel may be required for study execution or site support
Maximum Salary (US): 128000
Minimum Salary (US): 69000
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