R&D Engineer - Human Factors - Sysmind, LLC

JOB DESCRIPTION

List 3-5 hard requirements for the role:

o Requires in-depth knowledge and experience of human factors as well as cognitive psychology theory and application; the software development process, software technology, and effective methods of working with R&D teams; customers, trends, governmental factors and emerging research and technologies affecting product usability.

o A qualified record of implementing new processes to existing human factors and related systems.

o Documented record of delivering software engineering information which adds value to management's decision-making process.

o Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

o Ability to travel approximately 10%, including internationally.

List any preferred requirements that would stand out on a resume:

o Experience working on U.S. Food and Drug Administration (FDA) regulated, class 2 or class 3 medical devices or combination.

o Knowledge of insulin-requiring diabetes / strong diabetes disease state and diabetes product knowledge.

o Understanding of Quality System Regulations (QSR), including maintenance of a Design History File (DHF)/Usability Engineering File.

o Strong interpersonal and communication skills in both written and verbal form.

List Top 3 Skills you are looking for:

o Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

o Multitasks, prioritizes, and meets deadlines in timely manner.

o Strong organizational and follow-up skills, as well as attention to detail

Years' of experience required: 5+

Required education level/certifications: Bachelor' Degree in Human Factors Engineering, Experimental Psychology, Cognitive Psychology, Industrial Design, or a related field.

Daily tasks/duties and department interactions:

o Apply human factors expertise to the definition, design, and evaluation of products within the R&D division of Abbott Diabetes Care

o Apply knowledge of human factors principles (human performance and limitations perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to continuous glucose monitoring product development

o Deliverables include but are not limited to: Usability engineering files; Task analyses; Usability risk analyses.

o Experience working as part of a cross-functional, multidisciplinary team

Years' Experience: Minimum of 5 years of relevant human factors/usability engineering experience in hardware-software systems product development; prefer 10+ years' experience

Skills: Proven ability to work with multidisciplinary teams that may include other human factors expert; proven ability to interface with customers in a highly professional manner; proven ability to apply user-centered design and human factors/usability engineering principles to product research, development and design; experience in medical device development; ability to quickly assimilate advanced domain knowledge; excellent verbal and written communication and presentation skills

Education: M.S. degree in Human Factors Engineering or Cognitive Psychology or M.S. degree in Biomedical Engineering with extensive human factors coursework

Duties: Experienced R&D Engineer Human Factors to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of Electrophysiology Systems, which is part of the Atrial Fibrillation business unit.; apply knowledge of human factors principles (human performance and limitations perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to cardiac electrophysiology systems product development; 0rganize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization. Deliverables include, but are not limited to: Usability engineering files; Task analyses; Usability risk analyses; Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs. Develop collaborative working relationships with other functions across the organization, including but not limited to the following; Work with regulatory affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies; Work with design quality to ensure that the company's usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business. Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering; Represent in meetings with regulatory agencies, at human factors professional meetings and conferences, and as a member of standards committees.

SYSMIND LLC is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without any discrimination. We promote and support a diverse workforce at all levels in the company. All job offers are contingent upon completion of a satisfactory background check and reference checks. Additionally passing the drug test may also be required. All contractors intending to work on SYSMIND's W2 are "at will" employees.