Job Description

• Conduct research into the feasibility, design, operation and performance of mechanisms, components and systems
• Support the technical team in the development and review of Design History File (DHF) documents including Design Inputs, Design Outputs, Design Verification & Validation Plans/Reports, Test Methods, Usability Testing, etc.
• Participate in design, technical, and risk reviews to ensure adherence to quality and regulatory requirements.
• Ensure proper documentation of design change activities and conduct appropriate impact and risk assessments.
• Plan and manage projects, and prepare material, cost and timing estimates, reports and design specifications for medical device and systems
• Perform investigations to resolve non-conformances, and aid in implementing corrective/preventive actions (CAPA)
• Maintain technical content of the product’s risk management files, Design History File (DHFs) and Device Master Records (DMRs)
• Collaborate with cross-functional teams to improve design for manufacturability (DFM), and reliability.
• Support technical team in evaluating prototypes including inspection, product performance testing, data analysis, and reporting.
• Support quality assurance with internal and external regulatory audit activities.

Required languages: English

Education level: Bachelor’s degree in engineering or in a related engineering discipline is required

Required skills: Previous research and development with technical industry exposure, experience with statistical analysis tools, and benefit-risk assessments, product development

Additional skills / Assets: AutoCAD, MS Windows, Data analysis software, MS Excel, SolidWorks software, Computer-aided design, MS Office

Closest intersection: 3710 33 St NW, Calgary, Alberta, T2L 1M1