Michèle Touchette Email & Phone Number

Vancouver, BC, CA

Vancouver, British Columbia, Canada

• Design and development of a permanently implantable structural heart repair device for the mitral valve
• Rapid prototyping, development of drawings, and development of design specifications to meet design requirements.
• In-house machining & vendor outsourcing throughout manufacturing of device implant and ancillary tools
• Management of pre-clinical testing for implant device and delivery systems in preparation for EFS submission to FDA
• Development of durability test methods for device implant in preparation for EFS submission to FDA

Vancouver, Canada Area

• Design and development of a permanently implantable structural heart repair device for the mitral valve
• Prototyping and testing of percutaneous delivery systems
• Development of drawings and design specifications to meet design requirements.
• Verification & validation activities to support regulatory submissions.

Vancouver, Canada Area

• Perform root cause investigation and failure analysis for product & manufacturing process issues
• Manage product & process risk assessment
• Approver for engineering drawings, process specifications, and manufacturing/inspection procedures.
• Plan, execute, and review validation & verification activities in the plant
• Enforce compliance with applicable regulatory requirements and medical standards
• Perform internal audits as a Technical Subject Material Specialist for other medical device manufacturing sites

Vancouver General Hospital: Centre For Hip Health And Mobility

• Developed an Artificial X-ray Imaging System that retrofits mobile C-arm fluoroscopes for use during image-guided orthopaedic surgeries, as well as for radiation technologist education;
• Designed and completed a clinical user trial consisting of surgeons and radiation technologists in order to assess the system's potential in reducing radiation in operating rooms, as well as to establish its utility as.

Vancouver, Canada Area

• Standardized patient for UBC's Faculty of Medicine: Acted as a patient with a pre-determined history and set of symptoms during the examination of medical school students at UBC, as well as for licensing exams with the.

• Engineers in Scrubs Teaching Assistant (Master's Program):
• Enabled medical innovation by facilitating interdisciplinary collaborations between engineers and key departmental surgeons in Vancouver through organization of regular project & design pitch “MedTech” cafes
• Applied my design and startup experience by providing guidance and mentorship to graduate design teams
• Supported engineering professors with teaching assistantship in three Engineers in Scrubs graduate courses

Burnaby, BC

• Children’s Medical Equipment Recycling and Loans Program (CMERLS) volunteer
• Inspected, maintained, and repaired mechanical and motorized medical/therapeutic equipment to be loaned to children to ensure safe and reliable equipment rentals.

Vancouver, BC

• Ensured high-quality design and manufacturing processes by writing detailed quality-controlled engineering work instructions for the company’s medical device products
• Ensured ISO 13485 adherence by developing product verification and validation test protocols and reports for CE approval
• Performed highly meticulous inspection procedures in ISO Class 7 cleanroom and detailed pre-sterilization cleaning procedures in HEPA Laminar Flow Hoods

Vancouver, BC

• Ensured successful implementation and completion of clinical trials on ankle arthoplasty and arthrodesis;
• Wrote ethics applications, grant applications, budgets, as well as recruited volunteers and employees for foot and ankle research projects;
• Developed and maintained extensive Microsoft Access databases, performed detailed data analysis using Excel & SPSS, and wrote professional technical reports for surgeons and industry sponsors;
• Maintained clinical study participant enrolment by coordinating and performing study follow-ups with orthopaedic surgeons and their patients.

Mbabane, Swaziland

• Helped build homes for the S.O.S. Children’s Village in Swaziland through brick laying, as well as by coordinating work between local builders, Canadian volunteers, and material suppliers;
• Enabled school teachers to tutor older & high-potential children in the village by taking over kindergarten teaching activities with younger groups of children.

Montreal, Québec

• Ensured proper access to all necessary tools and devices during upcoming angioplasty procedures by thoroughly stocking and organizing surgical supplies, as well as by supporting surgery table setup;
• Allowed angioplasty nurses to focus on preparing the patients for surgery adequately by providing them with the proper medical supplies while addressing patient's questions and concerns.

Master Of Applied Science, Biomedical Engineering

Activities and Societies: Engineers in Scrubs Program (NSERC funded)Design & Thesis based Master's -- Development and validation of an.

Bachelor Of Applied Science (Basc), Mechanical Engineering (Biomedical Specialization), With Distinction

Baccalauréat 120 Crédits, With Academic Excellence

Bachelor Of Arts (Ba), Communication Studies, Dean'S Honour List