Worrell is searching for a project leader for our Human Factors group. You will represent Worrell as a subject matter authority for our clients and internal stakeholders with the aim to improve the safety and efficacy of the devices in development. You will be a known resource to the client and be responsible for delivering outstanding work with high-touch clients. From a team perspective, your leadership goals will be to drive higher standards of quality and integrity within the team.
- Responsible for directing and coordinating all human factors activities necessary to complete a major product development program or several small projects.
- Perform usability studies (formatives and summative) for hardware, software, and disposable products.
- Define user needs/requirements including ethnographic research, use case analysis, and/or task analysis.
- Perform formative usability studies during concept development and summative usability studies for human factors validation.
- Participate in analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations
- Guide clients through the human factors process using humility, professionalism, and expertise.
- Create and communicate plans and deliverables and manage time to meet deadlines. This includes reporting pertinent information at key milestones through clear, concise oral and written communications.
- Provide technical supervision to less experienced human factors engineers.
- Lead efforts to develop processes and procedures that align to Worrell initiatives and relevant human factors standards per FDA guidelines and international standards.
- Engage in personal ongoing learning programs to broaden knowledge in human factors engineering and to grow capabilities in new fields of user experience design in order to improve individual effectiveness.
- BS in Human Factors or a closely-related field with 5+ years’ experience; MS or higher in Human Factors or a closely-related field with 3+ years’ experience. Experience must include working on and leading the human factors design and evaluation of medical, business or consumer products.
- Proven experience in HFE principles – ergonomics, human computer / machine interface, and data collection / analysis methodologies.
- Proven experience in the effective implementation of HFE requirements /standards.
- Proven experience designing and performing usability studies (formative/summative) and use-related risk analysis.
- Ability to solve HFE problems with minimal assistance.
- Ability to decompose complex problems into actionable task lists.
- Demonstrated ability to provide technical leadership for HFE projects with substantial complexity and scope
- Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (i.e. Marketing, Manufacturing, Quality, Regulatory, etc.)
Demonstrated understanding of user centered design, heuristic evaluations, design of experiments, and statistical analysis.
Proven communication skills and ability to perform within a cross-functional team environment.
Proven ability to manage client expectations and deliverables while maintaining excellent client service.
Experience with FDA regulated environment and/or medical products/healthcare applications. Understanding of current medical device Human Factors standards and FDA Guidance (i.e.. ISO/IEC-62366-1, ANSI/HE-75, etc.)
Ability to travel up to 30% of the time, including local, domestic, and international