Location: Onsite

Status Type: Full Time

QUALIFICATIONS:

Required:

• 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)

Preferred:

• 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

Skills & Competencies:

• 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 workstreams, 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 others
• Influences without direct authority; maintains rational and objective demeanor when faced with stressful situations

Physical Requirements:

• Ability to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment e.g., printer, telephone, etc.)
• Ability to work in an open office environment, on-site at an Enable location

RESPONSIBILITIES:

• Lead human factors and usability engineering activities in compliance with FDA, IEC, and ISO standards (including FDA HF Guidance, IEC 62366-1, and ISO 14971); develop and maintain Human Factors Engineering (HFE)/Usability Engineering Files
• Lead formative usability studies, contextual inquiries, user interviews, and task analyses either directly or through an agency; lead and moderate summative (validation) usability studies, including protocol development and reporting (either directly or through an agency)
• Translate user needs, workflows, and pain points into actionable design inputs and requirements; lead the discussion with engineering, quality, and regulatory teams to influence device design and labeling
• Lead the creation, review, maintenance and harmonization of Instructions for Use (IFU); ensure IFU content accurately reflects validated user workflows, risk mitigations, warnings, and regulatory requirements; manage IFU updates through design changes and post-market feedback
• Lead the team in the identification, analysis, and mitigation of use-related hazards and risks; execute risk management documentation; ensure traceability between user needs, hazards, mitigations, and design solutions
• Provide human factors input during design reviews, design changes, and risk assessments; support design transfer and post-market activities related to usability and user feedback
• Standardize and harmonize the inputs towards and review human factors documentation for regulatory submissions (e.g., 510(k), PMA, CE Mark); support interactions with regulatory bodies and respond to usability-related questions or deficiencies
• Identify and drive best practices on programs/projects; ensure consistency and thoroughness of deliverables
• Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as key contact for program; establish credibility with pharma partner
• Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work independently
• Leverage team skills and experience to achieve human factors goals; communicate clear expectations to team members in order to meet deadlines
• Identify and help resolve business and process issues; drive a culture of quality and continuous improvement
• Implement necessary changes to maintain compliance with new and changing processes on programs/projects
• Model teamwork, diversity, and inclusion within team, between teams and other groups
• Operate effectively in a dynamic start-up environment; be willing to lead tasks outside of immediate responsibilities to contribute to overall team success
• Be inquisitive; foster curiosity; seek to understand the "why" behind processes and ideas and be a role model of change towards improving them