Human Factors Engineer / Scientist - PST

Planet Pharma is seeking a Human Factors Engineer / Scientist to facilitate HF/UE research and development for drug delivery device interface systems. The role involves collaborating with various teams to ensure product safety and effectiveness while supporting human factors and usability engineering activities.

Responsibilities:

• Partner multi-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, and commercial to ensure products are safe and effective for end users
• Support appropriate human factors and usability engineering activities to improve the design of products, specifically the user interface, including the device, packaging, labeling, and use instructions
• Implement a risk-prioritized approach appropriate for HF/UE activities
• Ensure Human-system capabilities and limitations are accurately considered, evaluated and reflected in system requirements, and HF/UE input is provided across functions to develop device design, packaging, labeling, and training requirements
• Analyze objective and subjective data from usability studies to inform design and risk assessment activities, as well as provide alternative patient and user solutions
• Moderate and/or support note taking and analysis of study data for formative and summative studies
• Prepare documentation to support development activities and design controls including usability plan, context of use, use specification, task analysis, use-related risk analysis, usability technical assessments, HF formative reports, and HF validation reports
• Communicate regularly with key internal and external partners
• This position requires up to 10-15% yearly domestic travel in the US

Requirements:

• Use-Related Risk Analysis (USSR)
• Validation Report, Summary Report
• Contribute to and facilitate HF/UE research, development and continuous improvement activities for drug delivery device interface systems
• Employ HF/UE standard processes in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries
• Effectively collaborate with internal and external partners including marketing, engineering, risk, quality, safety, manufacturing, and regulatory teams
• Drive the creation of innovative and intuitive products for patients and users
• Support appropriate human factors and usability engineering activities to ensure the product user interface-design adequately supports safe and effective use
• Partner multi-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, and commercial to ensure products are safe and effective for end users
• Support appropriate human factors and usability engineering activities to improve the design of products, specifically the user interface, including the device, packaging, labeling, and use instructions
• Implement a risk-prioritized approach appropriate for HF/UE activities
• Ensure Human-system capabilities and limitations are accurately considered, evaluated and reflected in system requirements
• Provide HF/UE input across functions to develop device design, packaging, labeling, and training requirements
• Analyze objective and subjective data from usability studies to inform design and risk assessment activities
• Provide alternative patient and user solutions
• Moderate and/or support note taking and analysis of study data for formative and summative studies
• Prepare documentation to support development activities and design controls including usability plan, context of use, use specification, task analysis, use-related risk analysis, usability technical assessments, HF formative reports, and HF validation reports
• Communicate regularly with key internal and external partners
• This position requires up to 10-15% yearly domestic travel in the US
• Remote - Located in PST is preferred