Job Description
A reputable client of ours in the medical device industry is looking for a Senior Human Factors Engineer. This person will primarily be supporting PCI Guidance projects within the Interventional Cardiology division. Cardiology division. This role will utilize a variety of new and proven technologies to deliver life-changing medical devices to patients and clinicians in support of BSCs mission. This role will apply Human Factors Engineering (HFE) principles to our products across the entire product development lifecycle for complex medical device systems by partnering with engineering, marketing, design assurance, project managers, clinical, regulatory, and marketing. Key responsibilities include planning and execution of human factors activities throughout the product development cycle to ensure that products are safely & effectively used by our customers.
Responsibilities:
* Perform activities in partnership with functional engineering groups quality, regulatory, marketing, clinical, and R&D to ensure that those products are safe and meet the needs of the customers.
* Interface with clinicians and other device users to collect user data (both objective and subjective) on systems.
* Provide HFE input based on research, evaluations, and literature to the product teams to enable design of user interfaces.
* Perform task analyses, use error risk analysis, heuristic analysis, competitive analysis, and contextual inquires. Plan and execute formative and summative studies.
* Apply knowledge of device users and use environments to the design and development of new products and product changes.
* Generate protocols and reports for usability studies, as well as usability engineering plans and reports.
* Deliver verbal, written and visual communications, with an emphasis on problem framing, visual storytelling and strong information design.
* Keep abreast of regulations and best practices for medical device human factors.
Qualifications:
* BS in Biomedical, Mechanical, Industrial, or other Engineering with experience or degree related to Human Factors
* Human Factors work experience (primarily in medical device or related field): 4 years with BS, or 3 years with MS Human Factors Engineering experience planning, coordinating, conducting, analyzing, and reporting formative human factors studies.
* Experience with various Human Factors methodologies such as ethnographic research, contextual inquiries, knowledge and comprehension studies, expert analysis, task analysis, use error risk assessment, usability formative studies, and summative studies.
* Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
* Ability to be collaborative and flexible in approach to solving user interface related challenges.
* Ability to clearly communicate how study results can be implemented into design, including analyzing and synthesizing large quantities of information into usable content for project teams and the business