You will join a team of mechanical, electrical and software engineers responsible for developing Medtronic’s Robotic Assisted Surgery platform through commercial launch and production scale-up.
Impact patient outcomes. Come for a job, stay for a career
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
SURGICAL INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
A Day in the Life
This position is in the Boston, MA Seaport District. You will be collaborating on an exciting, challenging, and fast-paced project for a new Surgical Robotics Platform. Your focus will be on evaluating new designs for fit with surgeons’ and OR staff’s expectations and abilities, with an eye towards safety and ease of use. Specifically, this position will be responsible for administering usability testing, completion of risk analysis for use-related issues, and other human factors program activities that support documentation for the design history file.
- Usability testing of prototypes with actual end users
- Use risk analysis
- Creation of design guidance to reduce use risk and improve ease of use
- Procedural observation, contextual inquiry
- Interviews of clinicians
- Maintenance of human factors program documentation
- Participation in planning of human factors program activities
- Regulatory oversight and preparation of usability-related regulatory documentation for market-approval submissions
Must have: Minimum qualifications: A Bachelor’s Degree and 8+ years of relevant experience.
Nice to have:
- BS in Human Factors or a closely-related field with 8+ years’ experience; MS or higher preferred with 5+ years’ experience
- Experience planning, conducting, and documenting usability testing in a medical device use context; ability to generate design guidance that addresses usability testing findings preferred
- Experience planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)
- Experience with risk analysis as specifically applied to human factors (e.g., AFMEA, UFMEA, URA techniques)
- Experience interacting with FDA and other regulatory bodies in the context of new product approval submissions preferred (e.g., 510k and PMA; related in-person meetings)
- Experience with strategic planning of medical device human factors program activities preferred
- Prior experience overseeing junior staff and outside contractors a plus
- Experience working with complex devices involving both software and hardware preferred
- Capable of working independently as the “local expert” in human factors and usability
- Excellent analytical, organizational, oral communication, and written communication skills required
- Detail-oriented with strong commitment to quality and to the workplace with the ability to efficiently multitask
- Interact and communicate with all levels of employees, as well as suppliers, customers and peers effectively.
- Must be willing and able to travel ~25% of the time primarily between Boston and North Haven facilities via car or train as well as domestically and internationally at times.
- Software skills: Microsoft Office (Word, Excel, PowerPoint, Project); experience with qualitative analysis tools (e.g., Morae, Atlas, NVivo) is a plus