IQ Inc. is assisting a local Pittsburgh client in the search for a Principal Human Factors Engineer. This is a growing, medical device company. If you are looking for a role that has an impact on people's lives, please consider applying for this position.
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
Supervisory Responsibilities: None.
Qualifications: 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. degree in biomedical engineering, psychology, or related field and a minimum of 10 years of usability experiences in medical device development
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
IQ Inc. is a woman-owned small business headquartered in Murrysville, PA. Since 1994 IQ has delivered software development and consulting services in ways that best meet our customers’ needs; including complete end-to-end software projects in our state-of-the-art development center. IQ also services our customers through staff augmentation engagements, contract-to-hire and direct placement. We work with our clients to create partnerships not just business relationships.