We are currently recruiting for a Specialist – Human Factors Verification & Validation in our corporate office in Alpharetta, GA.
The purpose of this role is to lead all Human Factors verification and validation activities from development to commercialization for the Surgical and Infection Prevention Business Unit, and assist in all aspects of customer research and technical claims support. This position requires someone with a passion for understanding the needs of target customers, and the ability to work closely with his/her technical and cross-functional colleagues to develop clear customer requirements and statistically valid conclusions. This role will also support and at times lead various R&D programs ranging from new product development through business support.
This person will support business objectives and product initiatives within the Surgical and Infection Control Business Unit. Collaborate with cross functional disciplines in support of Usability Engineering File. Support Human Centered Design team to champion human factors engineering, and coach and guide organizational teams to help teach methodology and ensure organizational success.
Work with colleagues to manage all customer based V&V S&IP activities supporting gloves, drapes, gowns, apparel, sterilization wrap and facial masks and other new product development through commercialization.
Work with his/her technical and cross-functional partners to define customer requirements, translate user needs and provide statistically valid conclusions.
Provide direction to facilitate and coordinate hospital in-use studies.
Coordinate and manage all nurse panel studies.
Coordinate and manage all sensory science studies.
Coordinate and manage the Simulated Use testing and in-use observation based research.
Work with cross-functional teams to manage technical based claims, support studies and manage database.
Work with colleagues to develop and manage competitive benchmarking studies and the resulting database.
Develop and manage a process for integrating human factors into customer requirements as a multidisciplinary approach from psychology, engineering, industrial design, graphic design, statistics, and anthropometry to support the development of S&IP devices that fit the human body and its cognitive abilities.
Plan and carry out assignments responsibly with minimal assistance and direction.
Communicate and document project plans and results to key customers.
Develop knowledge and skills to be recognized as an effective implementer of research principles, scientific analysis, and project management.
Requires a minimum of a Bachelor’s or advanced degree in a related major scientific or engineering discipline from an accredited college or university.
Requires a minimum of 6 to 10 years of experience in a variety of team based technical assignments.
A demonstrated ability to work independently and as an integral part of a team to complete projects within required timeframes.
Demonstrated accomplishments specific to the successful verification and validation of new medical devices (required) and OTC products (preferred).
Requires strong working knowledge of formative and summative verification and validation requirements for medical device development and advanced customer research, human factor and sensory science skills.
Demonstrated ability to manage multiple, complex assignments and customer/panel based research.
Working knowledge of design control practices and medical device regulations.
Strong working knowledge of market research methodologies, statistics and claims support.
Ability to drive projects forward quickly and effectively.
Strong knowledge and background in medical device product/technology development is desired. A demonstrated ability to translate that knowledge into execution of process or product related initiatives.
Strong knowledge and background in customer based verification and validation study requirements, human factor analysis and sensory science skills.
Demonstrated customer based work experience and category knowledge that spans Halyard’s Surgical and Infection Prevention medical devices portfolio.
If you are a current employee of Halyard Health, please apply here.