Manager, Human Factors

Enable Injections Inc.•Sharonville, OH

1d•Onsite

About The Position

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

Requirements

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)

Nice To Haves

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

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