Course Lecturer BMDE 656 Medical Device Development Process

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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: Todays 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 REQUIREMENTS

• Understand 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/ Éducation

Bachelor of Science Engineering or Arts

Experience/ Expérience

More than 5 years in medical device reimbursement

Other/ Autre

Fluency in English and French (written and verbal) preferred

This 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.

Disclaimer

Please 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 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.