Manager, Human Factors (Cincinnati, OH, US, 45241)

Cintrifuse; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Cintrifuse in Cincinnati, OH, is seeking a senior Human Factors Engineer to lead usability engineering activities in compliance with FDA, IEC, and ISO standards. You will develop and maintain HFE/Usability Files and supervise formative and summative studies to support regulatory submissions.

You will translate user needs into design inputs, collaborate with engineering, quality, and regulatory teams, and manage IFUs, risk assessments, and post-market activities.

Qualifications

• Bachelor's degree in engineering, design, psychology, or human factors.
• 8+ years in a regulated industry, preferably in medical devices/pharma.
• Experience leading cross-functional, matrixed teams and usability studies.
• Familiarity with ISO, FDA, MDD regulations and IEC 62366-1.
• Experience interfacing with external customers and contractors.
• Proficient in MS Office (Word, Excel, PowerPoint, Project).

Responsibilities

• Lead human factors and usability engineering activities per FDA/IEC/ISO standards.
• Conduct formative and summative usability studies with or via agencies.
• Translate user needs into design inputs; influence device design and labeling.
• Create and maintain IFUs; ensure content reflects validated workflows and risks.
• Lead risk analysis and mitigations; ensure traceability to design solutions.
• Provide HF input during design reviews and post-market activities.
• Harmonize HF documentation for regulatory submissions and communications.

Skills

Cross-functional leadership

User-centered design

Qualitative & quantitative data

FDA/IEC regulatory understanding

Project management

Communication

Problem solving

Team leadership

Microsoft Office

Education

Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors

MBA or MS in Engineering, Industrial Design, Psychology, or Human Factors

Tools

Microsoft Office

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