Registered Nurse (RN) Infusion Pump Design Validation

Job title: Registered Nurse (RN) Infusion Pump Design Validation 
Location: Round lake, IL (onsite)   5 Days onsite 
  
Candidate must have below details mentioned in yellow. 
  
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

  
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

  
Impact of the Role 
This position plays a critical role in ensuring infusion pump systems are intuitive, safe, and effective for healthcare providers and patients. The RN s clinical perspective directly influences product usability, risk reduction, and overall patient safety outcomes.