Human Factors Engineer in Thousand Oaks, CA at APEX Systems

Date Posted: 8/21/2019

Job Snapshot

Job Description

Job #:  982521


Apex Systems, has an opportunity for a Human Factors Engineer to work for one of our medical device clients in the Thousand Oaks, CA area.
We are seeking a Usability Engineer/Human Factors Engineer with 3+ years of experience in the medical device industry
 
For immediate consideration, please reach out to Alyssa Casey at email acasey@apexsystems.com.
 
Description:
The Human Factors Engineer (HFE) /Usability Engineer (UE) shall contribute to and facilitate HFE/UE research, development and continuous improvement activities of 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 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.
Responsibilities:
  • 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.
  • 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.
  • Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HFE reports.

Qualifications/Skillsets:
  • HFE/UE experience planning, coordinating, conducting, analyzing, reporting formative human factors studies without vendor support.
  • Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies.
  • Combination product experience including functional knowledge of applicable guidance, regulations and standards including:
    • FDA’s Human Factors Guidance, Labeling for home use, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Council Directive 93/42/EEC, Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.15 

 
 
 
 
 
 
 
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EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.