Engineer – HFE/UE (JP4907)
Thousand Oaks, CA
Final Product Technologies Usability Engineering
months with likely extension
3Key Consulting Inc. is recruiting for an Engineer with experience in HFE/UE , drug delivery medical devices or similar industry, for a global CA-based bio-pharmaceutical company.
The Human Factors Engineer (HFE) /Usability Engineer (UE) shall contribute to and facilitate HFE/UE research, development and continuous improvement activities of Amgen drug delivery devices using HF/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. HFE/UE collaborates with internal and external partners and across functions with marketing, engineering, quality, manufacturing, and regulatory teams. Implement human factors research to drive innovative and intuitive products. HFE will support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.
Must Have Skill Sets:
Candidate must have experience in human factors engineering or usability engineering in med device.
1. Human Factors Engineering / Usability Engineering experience planning, designing, executing formative studies.
2. Task analysis
3. Risk Assessment
4. Protocol and report authoring
5. Know and Understand relevant FDA guidance's
Employee Value Proposition:
- Manage HF aspects of project including: planning, timelines, milestones, deliverables, resources, priorities and budget required.
- Plan, conduct, analyze and report human factors activities supporting multiple projects.
- Assist in defining user needs, translation of needs into measurable specifications, evaluation of device-user interfaces, usability studies throughout Research & Development and Life Cycle Management phases.
- Ensure HFE/UE/ID input is provided across functions to develop device design, packaging, labeling, and training requirements.
- Ensure brand driven aesthetics are applied consistently across the entire product portfolio.
- Support usability testing such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, managing participant recruitment, study management, data collection, analysis, and documentation to support project needs.
- Assist in preparation for clinical studies and regulatory submissions in accordance with HF best practices.
- Analyze objective and subjective data from usability studies to inform design and provide alternative solutions.
- Active communication with internal and external key stakeholders.
- Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HFE reports.
Human Factors Engineering is a rapidly growing field and this individual will have the opportunity to join an industry leader in the space.
No HFE / UE No medical device
No industry experience
All experience research based
No direct study experience
phone screen with 2-3 team members 1/2 day onsite interviews start in Nov
We invite qualified candidates to send your resume to firstname.lastname@example.org
If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.