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Description

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. Develop and create evidence-based solutions to complex, applied human factors challenges for new or existing products. 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.

Responsibilities

• Human Factor Engineering:

  • Work on assigned projects providing Human Factors / Usability engineering support for activities at various stages of development within the MDIC R&D team.
  • Apply detailed risk-based process including identifying potential use-related hazards, mitigating those risks, and validating the risk mitigations are effective.
  • Conducting user inquiries, user studies, data gathering, data analysis and creation of detailed user requirement documents.
  • Design and execute studies that address both user behavior, user flows and user perceptions, using the right methodology for the right questions.

• Usability Engineering:

  • Develop, coordinate and conduct formative and summative user research studies, analyzing and reporting on use errors by compiling study reports

• Requirement Management:

  • Author, review and edit engineering documentation related to assigned projects

• Product Documentation:

  • Communicate regularly with internal cross-functional departments and external key partners.
  • Maintain ownership of human factor device specifications and participate in drafting pertinent sections of Regulatory Filings as directed.

• Product Validation:

  • Collaborate in the development of prototypes to explore and validate product design concepts

• Product Submission Support:

  • Support and provide HFE expertise in preparation for clinical studies and regulatory submissions in accordance with HF standard methodologies

• Product Design:

  • Provide design recommendations based on user needs and results from human factors formative and summative research across the product life cycle

Technical & Functional Skills:

• Proven track record in New Product Development with a focus in 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.
• Strong design and documentation skills
• Expertise in creating emulation model development to demonstrate product intent for user studies.
• Excellent project management skills along with Project Management Tools
• Excellent communication skills, including active listening and effective speaking.
• Determination and persistence                                                                                                                                             

Minimum Qualifications:

• Bachelors in Human Factors Engineering, Industrial Design Engineering or equivalent
• 5+ years Human Factor engineering
• 5+ years supporting hardware and software product

Preferred Qualifications:

• Demonstrated experience with system level design, integration, and validation of usability requirements and hazard mitigation associated with product development with an ability to gather and specify critical human factors system requirements, and clearly communicate design constraints and expected validation approaches across engineering disciplines.

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