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Sr. Engineer

Thousand Oaks, CA
SR. ENGINEER
 
Ultimate Solutions is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in United States, Puerto Rico and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.
 
Description
 
We are currently seeking for a Sr. Engineer for a temporary assignment to facilitate research, development and continuous improvement activities and drug delivery devices. The Sr. Engineer will support engineering activities to improve the design of products. The candidate must have solid GMP and regulatory experience.
 

Duties and Responsibilities

 
  • 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.
  • 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.
  • Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HFE reports.
  • Analyze objective and subjective data from usability studies to inform design and provide alternative solutions.
  • Active communication with internal and external key stakeholders.
  • Plan, conduct, analyze and report human factors activities supporting multiple projects.
  • 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.
 
 
 
Skills and Specifications
 
  •  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. 
  • Strong collaboration
  • Fully Bilingual (English/ Spanish)
 
Requirements
 
  • 5 + years of experience in pharma or medical device industry in a related field.
  •  Barchelor in Engineering (BSME, BSEE, BSChE and Industrial Engineer  preferred)
 
 
Ultimate Solutions USA, LLC an Equal Opportunity Employer
 
 
 
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