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 descriptionresponsibilities:
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.
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