Job Details

ID #20108402
State New Jersey
City Franklinlakes
Job type Contract
Salary USD Up to $42 42
Source Sunrise Systems, Inc.
Showed 2021-09-23
Date 2021-09-20
Deadline 2021-11-18
Category Et cetera
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UI / Human Factors Engineer

New Jersey, Franklinlakes, 07417 Franklinlakes USA

Vacancy expired!

Our client, a leading Medical Device company is looking for a UI / Human Factors Engineer This is for an initial duration of 12 months in Franklin Lakes NJ

Job Description:

Responsibility:
  • Writing/updating MA documentation (Clinical Development Plan, Clinical Evaluation Report, HFE report/executive summary)
  • Contributing to task analysis, use FMEA, IFU building and validation
  • Contributing to developing evaluation of Client products (methods and capabilities) to assess end-user’s acceptance, preference and willingness to adopt the medical device
  • Supporting development and execution of HF study (summative)
  • Participate in study vendor communications, training of study supplier; acquire signed supplier documents (contract) within study timelines, up to the approval of final payments
  • Clinical studies may range from simulated use studies (employing a patient or health care worker to use the device in a simulated environment; e.g. Human Factor studies) to complex studies in human subjects that may include drug/device combinations.

Position requirements:
  • Scientific background, (Biomedical Engineering, Masters or PhD in Biological Sciences, or PharmD preferred)
  • 3-5 years of preferably simulated studies experience, within the Pharmaceutical or the Medical device industry, with good understanding and knowledge of Medical device environment (including design control); regarding applicable Quality / Regulation, a good understanding and operational knowledge of national regulations and a good understanding of international regulations are needed.
  • The CHF-E should be an expert in study design and protocol development, and should be capable of critically evaluating protocols and have the ability to identify potential issues with the study design or implementation plan that might confound the results; he/she should also be conversant with statistical methods (understanding of main statistical methods used in C&HF trial analyses).
  • The successful candidate should have demonstrated ability in project management, particularly in effectively managing programs across reporting lines and:
  • Anticipate and prevent issues in studies, propose potential solutions
  • Acquire quickly an advanced knowledge of Client products and specific legislations (e.g. in the context of medical devices and Human Factors environment)
  • Possess excellent interpersonal skills, including the ability to perform well in a highly matrixed environment, and serve as an effective member of highly functioning multidisciplinary teams
  • Demonstrate fluency in written and verbal English, be highly organized, dynamic, confident, energetic, creative, pro-active, and open to new experiences and ideas
  • Demonstrate proficiency in using Word, Excel, Powerpoint, Microsoft project.

Vacancy expired!

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