Who we want
Challengers. People who seek out the hard projects and work to find just the right solutions.
User-focused creators. Engineers who design with the user in mind, developing products that helps change patients’ lives.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do
In this role you would be managing usability engineers, and other usability related disciplines responsible for designing suitable usability strategies and leading usability evaluations of key system components (software, robotic arm, guidance module, localization system, implants, and surgical instruments) in clinical environments.
• Manage resources and tasks to ensure timely and effective project completion according to the project plan.
• Partner with program management team members on establishing project scope, workload, priorities, and schedule.
• Develop and improve tools and processes to continuously enhance the quality of MAKO’s product line and efficiency in product development.
• Develop expert knowledge within the team of regulatory standards applicable to medical device and usability engineering: 21 CFR part 820, ISO 13485, ISO 14971, IEC, IEC 62366.
• Enforce the thorough application of MAKO’s quality procedure.
• Drive the usability formative and summative evaluations including definition of evaluation strategies, development and execution of protocols, data collection and documentation.
• Manage the development and maintenance of usability engineering deliverables for robotic projects, CAPA activities, complaint investigations, and system level formative and summative testing in collaboration with relevant program managers and project team leaders.
• Convey status to management and team members on a frequent basis. Articulate issues and make recommendations to the Program Managers and other senior management team members as appropriate.
• Work with Quality Assurance to establish and enforce standard practices for usability engineering team output.
• Develop a strong understanding of the clinical application of robotics product line for all team members. Understand clinical issues and system design to deliver product improvements that add value to the product users (patients, surgeons, OR staff, Stryker employees).
• Solicit and incorporate the input from surgeons, engineering, sales, marketing, quality assurance and operations to MAKO’s product lines.
• Oversee development and operation of usability engineering test lab.
What you need
•Bachelor’s degree in Human Factors, Usability Engineering, cognitive/experimental psychology or related discipline.
Master’s degree or higher in Engineering Program preferred.
•7 + years of experience in the medical device or other relevant industry(s) with focus on human factors engineering.
•Experience in formulating and analyzing both qualitative and quantitative usability test data as well as expertise in observing users in simulated environments.
•Possesses excellent interviewing skills, strong listening and observing skills, the ability to ask appropriate questions and communicate effectively
•Demonstrated experience with design controls in a regulated industry.
•Ability to lead complex technology engineering programs from charter phase through new product development
•Ability to manage direct reports, including developing, recruiting, and team building.