Registered Nurse(Infusion Pump Design Validation)

Detailed description/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

Qualifications & Experience

Minimum Requirements

• Active Registered Nurse (RN) license in good standing
• Infusion Pump
• Bachelor of Science in Nursing (BSN) required
• Minimum 2–5 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

Mandate 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