Principal Human Factors Design Engineer - Surgical Robotics
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Requirments: Must Have:
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A Bachelor’s Degree and 7 years of relevant experience, or advanced degree and 5 years of experience.
Nice to Have:
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BS in Human Factors or a closely related field (such as Biomedical Engineering, Industrial Design) with 8+ years’ experience; MS or higher preferred with 5+ years’ experience (specific experience in medical device development is strongly preferred)
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Experience planning, conducting, and documenting usability testing in a medical device use context; ability to generate design guidance that addresses usability testing findings preferred
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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)
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Experience with risk analysis as specifically applied to human factors (e.g., AFMEA, UFMEA, URA techniques)
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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)
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Experience with strategic planning of medical device human factors program activities preferred
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Prior experience managing junior staff and outside contractors preferred
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Experience working with complex devices involving both software and hardware preferred
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Capable of working independently as the “local expert” in human factors / usability
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Excellent analytical, organizational, oral communication, and written communication skills required
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Detail-oriented with strong commitment to quality and to the workplace with the ability to efficiently multitask
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Interact and communicate with all levels of employees within the Company, as well as suppliers, customers and peers effectively.
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Comply with policies, procedures, standards and rules of the Company.
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Maintain quality assurance policy consistent with standards.
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Maintain work area in a clean, orderly and safe manner.
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Punctual, regular and consistent attendance.
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Perform all other job-related duties as assigned.
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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.
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Must respond to changing requirements and working conditions including changing deadlines and project requirements and strict time constraints.
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Software skills: Microsoft Office (Word, Excel, PowerPoint, Project); experience with qualitative analysis tools (e.g., Morae, Atlas, NVivo) is a plus
Physical capabilities to perform the job:
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer and communicate with peers and co-workers via a variety of media including telephone, email, instant message, social networking platforms, and in-person meetings.
Work Environment
Office environment where the employee would be standing and sitting most of the day at a desk or in a conference room for meetings.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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 Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EEO
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
