MI Medical Writer Pharmacist

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