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COURSE DESCRIPTION
The Department of Biomedical Engineering of the Faculty of Medicine, McGill University, is seeking applications for a Course Lecturer for the 2025-2026 academic year to teach BMDE 656 Medical Device Development Process (3 credits) .
Course overview: Today's development of medical devices must be performed following existing standards such as ISO 13485:2016 for Europe, 21CFR 820 Quality System Regulation of the FDA (U.S. Food & Drug Administration), and MDSAP (international Medical Device Single Audit Program). These regulations and standards ensure that medical devices are developed in a controlled manner to ensure efficacy and safety for the patient and user. The development projects are milestone-driven and follow a structured development path.
Overview of all the development steps of a medical device, from a "back-of-the-napkin" idea or concept to subsequent use in humans. Discussion of the development of an existing medical device, review of all steps of the design process, including production of the required documentation in order to be able to complete a submission to a regulatory agency.
RESPONSIBILITIES
Preparing the students with the required knowledge, facilitating classroom discussions, assessing and evaluating student performance and preparing students to be successful leaders in their profession.
OTHER MAIN RESPONSIBILITIES INCLUDE:Preparation of course lectures and teaching materials
Preparation of assignments, tests and grading rubrics
Participation in curricular discussions
Hold regular office hours
TEACHING QUALIFICATION REQUIREMENTSUnderstand reimbursement definitions, concepts, and guidelines.
Understand how medical devices are used and paid for in the United States, Europe, and Canada, including the requirements of public and private reimbursement institutions.
Understand the best practices required to secure reimbursement for medical devices with regulatory clearance in the United States, Europe and Canada.
Understand how reimbursement strategies can significantly impact the innovation process.
Education/ Education
Bachelor of Science, Engineering, or Arts
Experience/ Experience
More than 5 years in medical device reimbursement
Other/ Autre
Fluency in English and French (written and verbal) preferredThis posting will expire at 00:00 am the day of the deadline to apply. You have until midnight the day before the deadline to apply to submit your application.
DisclaimerPlease note that, government directives permitting, it is anticipated that most courses will be taught in person. Should government restrictions prohibit in-person teaching, courses will revert to remote teaching. In the event of such a change, Course Lecturers will be advised without delay. Course Lecturers may be required to prepare and deliver teaching material suited to a remote/online teaching environment using a virtual learning platform (e.g., Zoom, WebEx) and the McGill myCourses learning management system. Training and assistance on remote teaching is available through Teaching and Learning Services (TLS) . Course Lecturers are encouraged to record their lectures.
Hiring Unit:
Biomedical Engineering
Course Title:
Medical Device Development Process
Subject Code:
BMDE 656
Location:
680 Sherbrooke, Rm 1165
Schedule:
Wednesdays 16:05 - 18:55
Deadline to Apply:McGill University hires on the basis of merit and is strongly committed to equity and diversity within its community. We welcome applications from racialized persons/visible minorities, women, Indigenous persons, persons with disabilities, ethnic minorities, and persons of minority sexual orientations and gender identities, as well as from all qualified candidates with the skills and knowledge to productively engage with diverse communities. McGill implements an employment equity program and encourages members of designated groups to self-identify. Persons with disabilities who anticipate needing accommodations for any part of the application process may contact, in confidence, accessibilityrequest.hr@mcgill.ca.
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