Manager of Human Factors and Usability Engineering
Balionis Group, Inc. is well known for providing engineers and technology people to a variety of high technology firms. We provide direct placement as well as contract engineers.
We are currently looking for a Manager of Human Factors and Usability Engineering for a permanent position within our client base. This position is permanent and is based in Pittsburgh, PA.
This position offers a huge opportunity for the right person. Our client is in the Medical Device Industry.
Essential Duties and Responsibilities:
Define and champion design thinking and usability research best practices within an agile organization by working closely with a cross-functional development team to ensure that user needs, usability requirements, and use errors are identified and addressed through all phases of the system lifecycle.
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 within the product development organization such as design quality, regulatory, engineering design, clinical development engineering, and product marketing.
Ensure the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies.
Apply FDA human factors processes towards the development of medical devices and follow the guidelines of the FDA and other regulatory bodies (e.g. IEC 62366, AAMI HE75).
Organize and direct the work of human factors engineering staff and outside consultants to effectively and efficiently support product development efforts within the company.
Lead the team’s collaborative work with the regulatory group to develop strategies for new product submissions, development process improvements, and respond to questions from regulatory agencies.
Recruit, develop, and retain high performing human factors and usability engineering staff.
Advance the development of the Human Factors engineering team by acting as a mentor and leader for less experienced Human Factors engineers.
This position has supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
Educations and/or Experience:
Requires B.S., M.S., or Ph.D. degree in biomedical engineering, industrial systems engineering, cognitive/experimental psychology, or related field (M.S. degree desired).
Minimum of 8 years of human factors and usability experiences in technology development (at least 5 years related to the medical device industry desired).
Minimum of 3 years of management experience required.
Understanding of Human Factors Usability Engineering process is required.
Experience with Human Factors FDA Guidance, and IEC 62366, and management of HF usability file for a medical device is required.
Demonstrated experience with development of complex instrumentation, especially with FDA Class II/III medical devices.
Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Basic mathematical skills required, including the understanding and ability to apply basic statistical and arithmetic principles, work with tabular data, and create and interpret graphs.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems and make appropriate judgment calls to insure the correct outcome.
To perform this job successfully, an individual should be proficient in Microsoft Office Suite, applicable test/development tools and associated technologies.
Upon request, the full position description will be released to the candidates.
Candidates need to be US Citizens or Permanent Residents.
Contact us for more information on the specific client and more details on the position description,