QUALIFICATIONS

Required:

• BS in Usability, Psychology (Cognitive, Experimental, Industrial/Organizational, or equivalent), Industrial Design, Industrial Engineering, Biomedical Engineering or related field
• At least 2 years of experience applying PD or HF principles; OR master’s degree in related field

Preferred:

• Experience in combination product development engineering in a pharmaceutical, medical device, regulated environment or related field
• Experience representing human factors body of work to regulatory agencies and during audits
• Experience working in matrix managed teams and participating on more than one project at a time

Skills & Competencies:

• Working knowledge and experience with applicable HF regulations and with ISO, FDA, International regulations, and ASTM standards such as:  IEC 62366-1, ANSI/AAMI HE75, ISO 14971, ICH Q9, ICH Q10, ISO 13485, MDR, 21 CFR parts 4, 820, 210 and 211, ISO 11608, FDA Guidance documents on: Medical Device Patient Labeling, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling – 21 CFR Part 801, and Use of Symbols – 21 CFR Part 801.15 
• Effective written and verbal communicator in team environments with strong interpersonal skills and can interface effectively with research, operations, and external suppliers and manufacturers. 
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required.

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time
• Ability to operate a computer and other office equipment, such as printer, telephone, etc. 

RESPONSIBILITIES:

• Generates detailed, high quality technical documentation to capture and communicate designs.
• Debates constructively and accepts ideas from others.
• Generates alternative solutions to problems or processes.
• Provides Product Development/Human Factors expertise across product range including identifying, planning, monitoring, and executing product development activities for projects to ensure safe usability.
• Collaborates in activities to develop the context of use and user needs/requirements including ethnographic research, use case/task analysis, and development of user profiles.
• Develops and directs formative usability studies during concept development and summative usability studies for Human Factors validation.
• Develops Statements of Work and contracts with external Human Factors vendors when needed to support workload of multiple projects.
• Writes clear test plans, set up test environments, manages recruitment of study participants, schedules research sites, moderates usability sessions, analyzes test results, identifies design improvement opportunities, and authors summary reports that adhere to industry standards.
• Performs analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations.
• Support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.
• Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and provide alternative solutions.
• Work collaboratively with engineering, design, commercial, and product teams to ensure successful translation of customer requirements into products that are safe and effective for user and enrich the overall user experience across Enable portfolio.
• Support and provide HF expertise preparation for clinical studies and regulatory submissions in accordance with HF best practices.
• Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, PD/HF technical assessments, PD/HF reports, and regulatory submissions.
• The position requires strong oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.
• Contribute to a dynamic start-up environment.
• Provide project status to leadership.