Manager, Human Factors

Cintrifuse; Cincinnati (OH); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Cintrifuse is seeking an experienced Human Factors Engineer to lead usability engineering activities and ensure regulatory compliance across FDA, IEC, and ISO standards. You will drive formative and summative studies, translate user needs into design inputs, and collaborate with engineering, quality, and regulatory teams.

The role requires a strong background in regulated medical devices, user-centered design, and cross-functional leadership, with on-site work in Cincinnati, OH.

Formación

• Bachelor’s degree in a relevant field and at least 8 years in a regulated industry
• Experience leading cross-functional, matrixed teams
• Experience in usability studies and data analysis; knowledge of user-centered design

Responsabilidades

• Lead human factors and usability engineering activities in compliance with FDA, IEC, and ISO standards
• Lead formative usability studies and summative studies; develop protocols and reports
• Translate user needs into design inputs; influence device design and labeling with engineering/regulatory teams
• Create, review, and maintain Instructions for Use (IFU) ensuring regulatory compliance
• Identify and mitigate use-related hazards; ensure traceability between needs, hazards, mitigations, and design solutions
• Support regulatory submissions and interactions with regulatory bodies; respond to usability questions

Conocimientos

Cross-functional leadership

User-centered design

Usability testing

Data analysis

Stakeholder communication

Regulatory liaison

Project management

Medical device experience

Team coordination

Educación

Bachelor of Science in Engineering

Bachelor in Industrial Design

Bachelor in Psychology

Bachelor in Human Factors

MBA

MS in Engineering/Industrial Design/Psychology/Human Factors

Herramientas

Microsoft Office

Descripción del empleo

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