Manager, Human Factors

Parkview Medical Center, Inc.; Cincinnati (OH); On-site; USD 110,000 - 160,000; Full time

Job summary

Parkview Medical Center, Inc. is seeking a senior Human Factors/Usability Engineer to lead HF and usability activities in compliance with FDA, IEC, and ISO standards.

You will drive formative and summative usability studies, translate user needs into design inputs, and guide risk management and IFU development. Responsibilities include collaborating with engineering, quality, and regulatory teams, supporting regulatory submissions, and mentoring cross-functional teams.

Qualifications

• Bachelor-level degree in Engineering, Industrial Design, Psychology, or Human Factors.
• 8+ years of experience in regulated industries, preferably 5+ years in medical devices, pharmaceuticals, or combination products.
• Experience leading product or process development activities.
• Minimum 2 years leading cross-functional, matrixed teams.
• Experience leading usability studies and analyzing qualitative and quantitative data; strong user-centered design knowledge.

Responsibilities

• Lead human factors and usability engineering activities in compliance with FDA, IEC, and ISO standards; develop and maintain HFE/Usability Files.
• Lead formative usability studies, contextual inquiries, user interviews, and task analyses; lead and moderate summative usability studies, including protocol development and reporting.
• 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.
• Harmonize and review human factors documentation for regulatory submissions (e.g., 510(k), PMA, CE Mark); support interactions with regulatory bodies.
• 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; work independently.
• Leverage team skills and experience to achieve human factors goals; communicate clear expectations to team members 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 and across groups.
• Operate effectively in a dynamic start-up environment; lead tasks outside of immediate responsibilities to contribute to team success.
• Be inquisitive; foster curiosity; seek to understand the 'why' behind processes and ideas; role model change.

Skills

Human factors engineering

Usability studies

Cross-functional leadership

Regulatory compliance

FDA guidance knowledge

IEC 62366-1

User-centered design

Contractor management

Education

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

Job description

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• 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

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
• 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 understandthe "why" behind processes and ideas and be a role model of change towards improving them