As a Design Specialist, in the Console Systems Department, your primary responsibility will be to develop medical equipment used in conjunction with disposables line of products and Accessories. The Design Specialist will work within the Console Systems team and under the Quality Management System (QMS). Responsibilities include developing, conducting, and evaluating new approaches to meet project objectives faster and more efficiently.
Job Functions / Responsibilities
- Drive the advancement of the product pipeline and bring new or improved products to market, initially;
- Develop and release console designs for peripheral and coronary systems for clinical studies;
- Develop and release next generation console iterations of products and associated accessories for Commercial Sales;
- Write protocols, perform bench testing, and write reports;
- Design and develop manufacturing tooling and methods;
- Contribute to Intellectual Property (IP) process and generate unique ideas and solutions;
- Supervise testing technicians;
- In collaboration with the Console Systems Team, complete Design History File (DHF) as per Design Control procedure and ensure all documentation is complete for successful regulatory submission and/or Audit.
Experience, Skills, and Knowledge Requirements
- Strong ability to apply knowledge and provide sound solutions to difficult problems;
- Medical Devices / Aerospace industry experience is an asset;
- Knowledge of ISO 13485 requirements and IEC 60601 is an asset;
- Effective written and verbal communications skills in both English and French;
- Experience with Solidworks CAD software;
- Intermediate to advanced MS Office skills;
- Ability to manage multiple tasks simultaneously;
- Possess strong project management skills;
- Strong interpersonal and collaboration skills.
- Minimum Bachelor’s Degree in mechanical or electrical engineering and/or equivalent field and/or relevant experience.