Manager, Human Factors

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Enable Injections, Inc. is seeking a Manager, Human Factors to lead usability engineering activities and HF documentation in a regulated healthcare setting.

The role involves coordinating with product, quality, regulatory, and manufacturing teams to align user needs with device design and labeling. The position requires extensive experience in medical devices or pharmaceuticals, strong collaboration with external customers, and the ability to manage contractors and cross-functional stakeholders

Qualifications

• Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors.
• Minimum 8 years in a regulated industry with 5+ years in medical devices/pharma/combination products.
• Experience in product or process development activities/process.
• Minimum 2 years leading cross-functional, matrixed teams.
• Experience leading usability studies and analyzing qualitative and quantitative data.
• Interfacing with external customers; managing contractors/consultants.
• Experience in other functional areas (quality, regulatory, PM, manufacturing, marketing research).
• Experience with ISO, FDA, MDD, and healthcare industry regulations and standards.
• Experience with FDA human factors guidance and IEC 62366-1.

Responsibilities

• Lead human factors and usability engineering activities compliant with FDA, IEC, and ISO standards; maintain HF Engineering Files.
• Lead formative usability studies and summative usability studies including protocol development and reporting.
• Translate user needs into design inputs; influence device design and labeling with engineering, quality, regulatory teams.
• Create, review, and harmonize Instructions for Use; ensure content reflects validated workflows and regulatory requirements.
• Identify and mitigate use-related hazards; maintain risk management documentation and traceability.
• Provide HF input during design reviews, risk assessments, and post-market activities.
• Harmonize HF documentation for regulatory submissions and interact with regulatory bodies.
• Identify best practices and ensure deliverables' thoroughness across programs.
• Develop relationships with pharmaceutical partners and internal teams; work independently.
• Support change management to maintain compliance with evolving processes.

Skills

Cross-functional leadership

Usability studies

User-centered design

External customer interfacing

Contractor management

Regulatory/regulatory compliance

Communication (written)

Project management

Risk management

Analytical thinking

Education

Bachelor’s degree in Engineering, Industrial Design, Psychology, or Human Factors

MBA or MS in Engineering/Industrial Design/Psychology/Human Factors (Preferred)

Tools

Microsoft Office (Word, Excel, PowerPoint, Project)

Job description

• 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

Qualifications

• 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

Nearest Major Market: Cincinnati