Details
Official title: Senior Human Factor Engineer II
Duration: 12 month W2 with EPM Scientific (possibility of extension or conversion)
Location: Hybrid 3 days onside in New Haven, CT (parking will be reimbursed) or Boston, MA (not reimbused)
Qualifications
- Experience in the medical devices and/or combination products
- Knowledge of regulatory requirements and human factor/usability engineering for device
- Experienced in design control, and life cycle management
- IEC 62366, 60601 , ISO 11608 & 14971, FDA QSR 21 CFR
Responsiblies
- Ensure all human factors engineering complies with QA & regulatory requirements
- Support activities under the HF and usability engineering process for the combination product
- Responsible for determining the strategy for niche focused engineering activities & lead user-related risk analysis
- Will work closely with other Human Factors specalized individuals & educate teamates on the the development
- Bachelor's in engineering
- Experienced in medical device development in Ergonomics / Human Experience with injector based combo products (plus)
