Manager, Human Factors

• Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors
• Minimum 8 years of experience in a regulated industry, preferably at least 5 years in medical devices, pharmaceuticals, and/or combination products
• Experience in product or process development activities/process
• Minimum 2 years of experience leading cross-functional, matrixed teams
• Experience leading usability studies and analyzing qualitative and quantitative data; strong understanding of user centered design principles
• Experience directly interfacing with external customers; experience directly managing contractors/consultants
• Experience in additional functional areas (e.g., quality, regulatory, project management, manufacturing, engineering, or marketing research)
• Experience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standards
• Experience with FDA human factors guidance and IEC 62366-1

Title: Manager, Human Factors

Location: Onsite

Status Type: Full Time

• Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors
• Minimum 8 years of experience in a regulated industry, preferably at least 5 years in medical devices, pharmaceuticals, and/or combination products
• Experience in product or process development activities/process
• Minimum 2 years of experience leading cross-functional, matrixed teams
• Experience leading usability studies and analyzing qualitative and quantitative data; strong understanding of user centered design principles
• Experience directly interfacing with external customers; experience directly managing contractors/consultants
• Experience in additional functional areas (e.g., quality, regulatory, project management, manufacturing, engineering, or marketing research)
• Experience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standards
• Experience with FDA human factors guidance and IEC 62366-1
• Proficiency utilizing Microsoft Office suite (Word, Excel, PowerPoint, Project)

• Master of Business Administration (MBA) or Master of Science in Engineering, Industrial Design, Psychology, or Human Factors (Preferred)
• Experience organizing resources, people, budget, milestones, and detailed activities for large-scale projects
• Experience managing people directly

• Leads cross-functional stakeholders and team, directly or indirectly, including driving accountability and responsibility for results and forward progress; facilitates teamwork and exhibits self-motivation
• Collaborates effectively with diverse stakeholders; demonstrates partner commitment and customer orientation
• Communicates effectively in writing, including ability to write in a clear, concise, logical, and grammatically correct manner
• Seeks to understand when listening to others; demonstrates awareness of what is requested; communicates orally in a professional manner that inspires confidence
• Exercises discernment in dissemination of information and sense of urgency; escalates issues to ensure timely and relevant responses; demonstrates ability to handle sensitive information with discretion and tact
• Demonstrates high attention to detail; conveys excellence in partner deliverables
• Distills complicated topics for intended audience; leads large discussions, and adjusts/adapts/responds to real-time feedback; communicates human factors information to audience and captures real-time feedback
• Executes strategic plans and work streams, including planning, organizing, securing, and managing resources to achieve goals
• Solves problems, including providing clarity in defining problem statements in ambiguous, complex situations; draws logical conclusions
• Sets clear goals, delegates effectively, and leverages the skills and expertise of…