Senior Human Factors Systems Engineer

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 inte...