Senior Human Factors Design Engineer
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Careers That Change Lives
At Medtronic Diabetes you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. As a Senior Human Factors Engineer you’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position is remote with 25-50% domestic and international travel required.
As a Senior Human Factors Design Engineer, you will help to execute human factors efforts within the Product Innovations organization, working in a fast-paced environment with a large team of human factors engineers while collaborating with systems engineers, UX designers, Clinical SME’s, Software Engineers, and Regulatory Experts. This position is focused on diabetes technology including software applications, insulin pumps, continuous glucose meters, and Smart Pens. Your focus will be on the integration of new technologies into our current platforms through the use of traditional med-device HFE practices. 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.
- Lead Human Factors projects supporting business portfolio,
- Moderating usability testing of prototypes with end users and customers,
- Aiding in data collection and root cause analysis during usability testing,
- Contribute inputs to design guidance to reduce use risk and improve ease of use,
- Moderate interviews with end users and customers for the purpose of gathering insights,
- Contribute and maintain human factors program documentation as needed for the UE File,
- Participation in planning of human factors program activities,
- Aiding team with preparation of usability-related regulatory documentation for pre-market approval submissions
- Aid in identifying use-related issues upon post-market launch and provide recommendations of risk control - enhancements
- Mentorship/coaching role to junior HF staff
Must have: Minimum qualifications:
- Bachelor’s degree and minimum of 4 years of relevant experience
- Or advanced degree with a minimum of 2 years relevant experience.
Nice to have:
- Experience planning, conducting, and documenting usability testing in a medical device use context; ability to generate design guidance that addresses usability test 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., UEA, Hazard Analysis, etc.)
- Experience working with complex devices involving both software and hardware preferred
- Capable of working independently and with limited oversight in human factors disciplines
- 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 within the Company, as well as suppliers, customers and peers effectively.
- Comply with policies, procedures, standards and rules of the Company.
- Maintain quality assurance policy consistent with standards.
- Must be willing and able to travel ~40% of the time primarily between your remote working location and major cities within the US, some international travel may be required.
- Must respond to changing requirements and working conditions including changing deadlines and project requirements and strict time constraints.
- Software skills: Microsoft Office (Word, Excel, PowerPoint, Project); experience with qualitative analysis tools a plus.
#LI-MDT
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are rep
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