Systems Engineering Senior Specialist needed for an Ontario company offering state of the art regenerative medical treatment to health care providers / patients. As a Systems Engineer, you will be deciding how to do design, integration and manufacture of complex disposable medical devices. You will be identifying the likeliest points of failure and finding solutions to these problems, with a constant eye to continuous improvement.
Location Eastern ON and relocation assistance provided.
ROLES AND RESPONSIBILITIES:
Conduct product design reviews and modifications to improve product reliability and quality, manufacturing efficiency, and greater production yields.
Responsible to address product performance and vision opportunities with respect to users needs.
DFA, DHF and DMR, complaints, root cause analysis, risk assessment.
Collaboration with a cross functional team to lead complex design updates and implementation of corrective actions related to product design.
Use your knowledge of ISO 13485 Quality Management System to generate and review all documentation such as mechanical drawing, technical reports and conceptual design.
B. Eng. (Biomedical, Systems, Chemical, Mechanical or related).
Experience in medical devices or other product design and manufacturing field.
History working with disposable (plastic) parts.
Extensive knowledge of CAD (preferably Solid Works).
Knowledge of manufacturing processes (injection molding, machining, 3D printing under QMS.
Design for Manufacturing and Design for Assembly experience.
PMP/ P Eng.
Experience with cell culture and bioreactor design.
Statistical analysis (eg Minitab).
rapidly growing company with room for personal growth
low cost of living area
state of the art therapeutic medical devices