For one of our clients we are looking for a Human Factors Engineer

Project name:
Software as Medical Device Projects

Project description:
The client is working on developing innovative software products which is supporting patients and health care professionals with their disease management. Some of these products will be developed as Software as Medical Devices (SaMD). The client as a legal manufacturer of SaMDs has set its goal to develop human-centered applications with a high quality, safety and user satisfaction.

Background to the assignment:

The client needs expertise in designing and developing compliant SaMDs. The contractor should apply relevant HFE standards and processes according to FDA guidelines and MDR (Medical Device Regulation). The client X does not have the suitable expertise for this internally, due to this needed special expertise, the external Contractor will have an outstanding position compared to the internal project staff and will perform significantly different services than the internal staff.
The project teams work self-organized in agile approach, blending scrum and Kanban.

Tasks:
- Performing all usability engineering activities as defined in the client quality management system, incl. Human factors (HF) studies / usability evaluation, and the related documentation.
- Formative and Summative evaluations in form of:
• Study planning based on research question, defined requirements, and therapeutic areas which include.
o Defining target participants for studies
o Writing characteristics and demographics for recruitment of patients.
o Defining critical tasks to be tested in Human Factors studies
o Individually preparing prototype for testing
• Analyzing, presenting, and documenting the synthesized study data to be compared to success metrics. The Analysis will be based on the Contractors experience.
• Translating findings and necessary changes according to the Risk Evaluation to Product Requirements
- Writing HFE/UE Summary Report
• Create a draft of the summary report based on the collected data
• Present and handover the draft for review to the client
• Create a final draft, based on feedback, and hand it over to the client
- Performing user research
• Summarize findings, creating use specifications, translating them into user needs and handing it over to the client as input to stakeholder and software requirements
- Activities related to Risk Management
• Performing task analysis & Identifying use related risks and hand them over to Risk Management
- Consulting on related functions such as labeling, medical, regulatory, project owners
• Providing input to Instructions for Use / User guidance based on experience and external requirements to be approved by the client
• Consults the UX design and frontend development team regarding usability

Required skills:

• Scientific or engineering Masters degree or similar qualifications, e.g. Human-factors
• Engineering, Human-machine Interface, Biomedical Engineering, Software engineering, Psychology.
• 5 years of experience in the medical device or pharma industry, preferably in a HFE, risk management or quality environment position
• Strong hands-on background expertise in documentation, usability files, technical files,
• Design history files and other regulatory submission relevant documentation and ability to
• Prepare documents for submission (HFE file and summary report)
• Excellent communication, presentation and organizational as well as basic project management skills
• Clear understanding and driver of user-centered design approaches
• Experience in performing usability research and HFE studies
• Openness to receiving feedback and constructive criticism. Ability to provide constructive feedback to colleagues
• Fluency in written and spoken English, German is a plus.

Start: ASAP
Duration: Till end of 2023
Location: 90% remote, 10% onsite (Ingelheim)