Senior Human Factors Systems EngineerLocation Raleigh, NC, USA
Provide human factor engineering expertise from product prototype and development through commercialization.
Work with R&D engineering to provide the necessary usability and validation testing to support FDA and EU regulations and product filings.
Lead efforts within multi-disciplinary teams, accomplishing human factors engineering activities involving representative end-users of systems, designers, software developers, and program stakeholders by planning and executing human factors studies to define and confirm safety for products.
Work on assigned projects providing Human Factors / Usability engineering support for activities at various stages of development within the MDIC R&D team.
Maintain ownership of human factor device specifications and participate in drafting pertinent sections of Regulatory Filings as directed.
Support and provide HFE expertise in preparation for clinical studies and regulatory submissions in accordance with HF standard methodologies
Requirements:
Proven track record in New Product Development with a focus on Human Factors, from concept to production.
Solid foundational experience in designing medical device and well versed with appropriate standards including IEC 62366-1 and -2, ANSI/AAMI HE75 and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices.
Strong understanding of the Product Development Life Cycle and advanced experience in human factors and usability engineering, human centered design and integration in regards to the requirements prescribed in ISO 9241-210 Human-Centered Design Process for Interactive Systems, ISO 62366-1:2015, 62366-2: 2016; FDA Guidance on Human Factors in medical devices (2016); and Content of Human Factors Information in Medical Device Marketing Submissions (2022); Medical Device Regulation EU IVDR 2017/746
Minimum Qualifications:
Bachelors in Human Factors Engineering, Industrial Design Engineering or equivalent
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