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 Principal Human Factors Engineer 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 a medical device firm, with a successful product on the market now. Newer versions of the product are being designed, along with additional complimentary clinical products being considered.
Our client is growing their R&D team, including their Human Factors Engineering group.
Essential Duties and Responsibilities:
Drive patient-focused product innovation by leading the development of human factors engineering processes within the organization, including the management of standard operating procedures.
Works closely with a cross-functional development team throughout a product development effort to ensure that user needs, usability requirements, and use errors are identified and addressed in the design process.
Lead analytic human factors activities (e.g., use FMEA, task analysis, heuristic evaluation) for the purposes of “design input,” risk assessment and mitigation, and protocol development
Lead the development and execution of formative and summative evaluations at various stages of product development from early prototypes through formal FDA-mandated validation
Work closely with development engineers and R&D Management to ensure the HF/UE process is followed through all phases of the system lifecycle.
Engage Quality and Regulatory to drive development of processes documentation to meet regulatory requirements
Collaborate with external Human Factor Engineering consultancies, internal stakeholders and partner organizations
Advance the development of the Human Factors engineering team by acting as a mentor and leader for less experienced Human Factors engineers.
Education and/or Experience:
B.S. degree in biomedical engineering, psychology, or related field.
5-7 years of Usability Experience in device/system development in a safety critical industry.
2+ years of Human Factors/Usability Experience within the Medical Industry.
Understanding of Human Factors/Usability Engineering process is required.
Proven successful FDA submissions with human factors component is required.
Experience with Human Factors FDA Guidance, and IEC 62366, and management of HF usability file for a medical device is desired
Leadership qualities and ability to be the Voice of Human Factors Engineering to other groups.
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.