Job Title: Sr Human Factors Design Engineer



Job ID: 11167



Location: 3850 Brickway Blvd, Santa Rosa California 95403



Duration: 12 Months



Pay Range: $50-$55/ hour on W2



HM's Top Needs:



Experienced in medical device usability regulatory standards and requirements. Knowledge of FDA Usability Engineering guidance document and regulatory body deliverables for Usability



Experience with Risk documentation architecture completed task analyses and inputting to UFMECA risk controls.



Experience conducting and reporting on Formative and Summative evaluations.



Education Required: Bach Degree in relevant Engineering / Science or related discipline If a Human Factors/Usability Engineering degree is a possibility that would be ideal. Advanced degree desirable but not necessary



A Day in The Life:



Applies human performance principles, methodologies, and technologies to the design of human-machine systems and products.



Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes.



Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users.



Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces by providing Human Factors support, including identifying, planning, monitoring, and executing Human Factors tasks for projects.



Develops task analysis, use error analysis, human factors and usability-related requirements, generation of concepts (creation of physical models and prototypes), graphical (software) user interface design, usability testing, risk management, and post-launch outcomes analysis.



Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.



Key Skills & Experience



Level 8 Degree in relevant Engineering / Science or related discipline. Advanced degree desirable but not necessary



5+ years relevant industrial experience in performing human factors engineering in medical device development.



You are experienced in medical device usability regulatory standards and requirements.



You are experienced in writing formative and summative usability test protocols and reports and designing instructions for use (IFU) documents.



You are experienced in moderating usability studies that have been used for regulatory submissions.



You have the ability to integrate creative skills with innovative problem-solving techniques to support development of design concepts.



You have experience completing field case research and case study observation with proven ability to apply findings into human interface requirements.



You are a dynamic team player, with a proven ability to integrate into and influence multidisciplinary teams.



You are a good communicator and have strong oral and written technical communication skills.



Travel expectation, up to 20% to Europe and United States



Responsibilities may include the following and other duties may be assigned. Applies human performance principles, methodologies, and technologies to the design of human-machine systems and products. Develops and implements research methodologies and statistical analysis plans, to test and evaluate developmental prototypes used in all phases of products development and processes. Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, userelated risk identification and formal usability validation with intended users. Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized humanmachine interfaces. Develops task analysis, use error analysis, human factors and usability-related requirements, generation of concepts (creation of physical models and prototypes), usability testing, risk management, and post-launch outcomes analysis. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.



Years Experience Required: 5 years.



Will the contractor be working 40 hours a week? If not, weekly estimate? Yes 40 hours.



Work Location: Ideally close to Santa Rosa site



Do they need to be local to any MDT office and if so, where?



Does this person need to be on site? If so, full time or part time? Part-time on site is acceptable but needs to commit to get onsite for specific activities.



Specialist Career Stream: Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).



Differentiating Factors Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.



Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Wilish



Associate Recruiter



Office:Ext 268, Cell: (phone number removed)



Email:



360 Mt. Kemble Avenue, Suite 2000 Morristown



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