- Company Name
- Innova Solutions
- Job Title
- Scientist Senior
- Job Description
-
**Job Title**
Senior Human Factors Scientist
**Role Summary**
Lead human‑factor and usability initiatives for drug‑delivery device interfaces in a fast‑paced, cross‑functional environment. Drive risk‑prioritized HF/UE activities, design improvements, and regulatory documentation to ensure product safety and effectiveness for end users.
**Expectations**
- Demonstrated success in health‑authority submissions (validation reports, summary reports, URRA).
- 3–5 years of industry experience in human‑factors engineering for injectable or minimally invasive drug‑delivery devices.
- Ability to partner with engineering, regulatory, quality, risk, clinical, drug product, digital health, and commercial teams.
**Key Responsibilities**
- Develop and execute HF/UE studies (root‑cause analysis, ethnographic research, focus groups, heuristic reviews, task analysis, risk assessment).
- Analyze quantitative and qualitative usability data to inform design and risk assessment.
- Prepare HF/UE supporting documentation: usability plan, context of use, use specifications, task analysis, risk analysis, technical assessments, formative and validation reports.
- Coordinate formative and summative studies, including low‑ and high‑fidelity prototype evaluation.
- Integrate HF/UE insights into device design, packaging, labeling, and training documentation.
**Required Skills**
- Strong written communication and documentation ability.
- Proficiency in HF/UE methodologies (ethnography, interviews, contextual inquiry, scenarios, focus groups, usability technical assessments, hazard and risk analysis).
- Experience in assessing and improving user interfaces of injectables, pens, needle‑free injectors, syringes, pulmonary or transdermal systems.
- Ability to conduct studies independently without vendor support.
- Practical knowledge of regulatory guidance, standards, and risk‑prioritization frameworks.
**Required Education & Certifications**
- Bachelor’s or Master’s degree in Human Factors Engineering, Usability Engineering, Medical Device Design, Mechanical Engineering, Industrial Design, Biomedical Engineering, Systems Engineering, or related field.
- Relevant certifications (e.g., Certified Usability Analyst, Certified Human Factors Professional) preferred.