Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors
8+ years in a regulated industry, with 5+ years in medical devices or pharmaceuticals
Experience in product/process development
2+ years leading cross-functional teams
Experience with usability studies and user-centered design principles
Direct interface with customers and management of consultants
Knowledge of ISO, FDA, MDD regulations and standards
Experience with FDA human factors guidance and IEC 62366-1
Proficient in Microsoft Office Suite.
Responsibilities
Lead human factors and usability engineering activities in compliance with FDA and ISO standards
Conduct formative and summative usability studies directly or through agencies
Translate user needs into actionable design inputs and collaborate with engineering and regulatory teams
Create and maintain Instructions for Use (IFU) ensuring compliance with user workflows
Identify and mitigate use-related hazards; execute risk management documentation
Provide human factors input during design reviews and risk assessments
Standardize and harmonize human factors documentation for regulatory submissions
Drive best practices in programs/projects and ensure delivery consistency
Develop and maintain relationships with pharmaceutical partners and internal colleagues
Identify and resolve business and process issues for continuous improvement
Model teamwork and inclusivity within and across teams
Thrive in a dynamic start-up environment and lead tasks beyond immediate responsibilities
Benefits
Comprehensive health coverage
Retirement savings plans with company match
Professional development opportunities
Flexible work arrangements
Paid time off and paid holidays
Employee wellness programs
Full Job Description
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
