Employers

Drug Device and Human Factors Engineer

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Job ID:

25906

Location:

Cincinnati, OH 

Category:

Business Development
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Job Views:

1332

Zip Code:

45241

Employment Type:

Full time

Posted:

03.17.2015
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Job Description:

Position Title:           Drug Device and Human Factors Engineer
Department:           Drug Device Development

                                       
Summary (Scope of Job):
 
  • Primary purpose of the job is to provide device development and human factors engineering support to Production and R&D activities.  This job contributes to the organization by providing design and design input to determine functional product requirements and features.  The position also organizes and oversees user preference and human factor studies. 
 
 
Major Responsibilities:
 
1. Contribute to human factors efforts for a range of platform programs for drug delivery devices.
2. Provide leadership in Human Factors / Usability Engineering in the design, development, testing, and commercialization of pharmaceutical delivery systems [medical devices] working closely with stakeholders in Regulatory, Quality, Manufacturing, Clinical and Commercial.
 
3. This individual will be working with early and late stage development programs as well as life-cycle management projects to evaluate device usability, perform usability risk analyses, design and conduct formative human factors studies, recommend and develop design improvements to address usability issues.
 
4. When appropriate, identify and partner with external human factors experts to develop protocols for and conduct formative and summative studies.
 
5. Write HF-related documentation such as HF summary reports, contribute HF sections to regulatory filings, develop and implement HF / usability engineering processes to ensure compliance with regulatory requirements.
 
6. Build relationships with the usability engineering communities, and serve as a subject matter expert on global human factors regulations, standards, and best practices.
 
7. Mentor, educate and direct personnel on Human Factors-related activities and processes.
 
 
 
Educational Requirements:         A degree in Human Factors / Usability Engineering, Mechanical Engineering, Industrial Design, Biomedical Engineering, or equivalent.
 
Experience Requirements:           A minimum of five years of experience in device development engineering in a pharmaceutical, medical device, regulated environment or related field is required.
 
Knowledge and Skills:                      Experience applying Human Factors / Usability Engineering, including design and execution of formative and summative studies, to the design and development of medical devices or consumer products is required. Working knowledge and experience with applicable HF regulations and with ISO, FDA, International regulations, and ASTM standards is required. The successful candidate must be an effective communicator in team environments with strong interpersonal skills and have the ability to interface effectively with research, operations, and external suppliers and manufacturers.  Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required.
Company Info
Enable Injections
2863 East Sharon Road
Cincinnati, OH, United States

Phone: 513-223-7301
Web Site: www.enableinjections.com

Company Profile