Senior Manager, Human Factors & Usability Engineering

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

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.