Head of Human Factors - Medical Devices

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Enable Injections, Inc. is seeking a Manager, Human Factors to lead usability engineering activities and HF documentation in a regulated healthcare setting.

The role involves coordinating with product, quality, regulatory, and manufacturing teams to align user needs with device design and labeling. The position requires extensive experience in medical devices or pharmaceuticals, strong collaboration with external customers, and the ability to manage contractors and cross-functional stakeholders

Qualifications

• Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors.
• Minimum 8 years in a regulated industry with 5+ years in medical devices/pharma/combination products.
• Experience in product or process development activities/process.
• Minimum 2 years leading cross-functional, matrixed teams.
• Experience leading usability studies and analyzing qualitative and quantitative data.
• Interfacing with external customers; managing contractors/consultants.
• Experience in other functional areas (quality, regulatory, PM, manufacturing, marketing research).
• Experience with ISO, FDA, MDD, and healthcare industry regulations and standards.
• Experience with FDA human factors guidance and IEC 62366-1.

Responsibilities

• Lead human factors and usability engineering activities compliant with FDA, IEC, and ISO standards; maintain HF Engineering Files.
• Lead formative usability studies and summative usability studies including protocol development and reporting.
• Translate user needs into design inputs; influence device design and labeling with engineering, quality, regulatory teams.
• Create, review, and harmonize Instructions for Use; ensure content reflects validated workflows and regulatory requirements.
• Identify and mitigate use-related hazards; maintain risk management documentation and traceability.
• Provide HF input during design reviews, risk assessments, and post-market activities.
• Harmonize HF documentation for regulatory submissions and interact with regulatory bodies.
• Identify best practices and ensure deliverables' thoroughness across programs.
• Develop relationships with pharmaceutical partners and internal teams; work independently.
• Support change management to maintain compliance with evolving processes.

Skills

Cross-functional leadership

Usability studies

User-centered design

External customer interfacing

Contractor management

Regulatory/regulatory compliance

Communication (written)

Project management

Risk management

Analytical thinking

Education

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

MBA or MS in Engineering/Industrial Design/Psychology/Human Factors (Preferred)

Tools

Microsoft Office (Word, Excel, PowerPoint, Project)

Job description

Enable Injections, Inc. is seeking a Manager, Human Factors to lead usability engineering activities and HF documentation in a regulated healthcare setting.

The role involves coordinating with product, quality, regulatory, and manufacturing teams to align user needs with device design and labeling. The position requires extensive experience in medical devices or pharmaceuticals, strong collaboration with external customers, and the ability to manage contractors and cross-functional stakeholders