Job details
Location: 3710 33 St NW, Calgary, Alberta, T2L 1M1
Salary: $110,000/annually
Vacancies: 1 Vacancy
Terms of employment: Permanent, Full time, 40 hours/week
Start date: As soon as possible
Employment conditions: Morning, Day
Job requirements
Languages: English
Education: Bachelor’s degree in engineering or in a related engineering discipline is required
Experience: Minimum 2 years experience in medical device, biotech or pharmaceutical industry
Area of work experience: Design, Research and Development, Risk Management, Medical instruments and devices.
Transportation/Travel Information: In-person, must have their own reliable vehicle and means of transportation.
Work Conditions and Physical Capabilities: Fast-paced environment, Combination of sitting, standing, walking, attention to detail, and working under pressure with tight timeline.
Work Site Workplace: Engineering firm
Personal Suitability: Initiative, Team player, Organized, Accurate, Excellent oral and written communication.
Specific Skills:
• 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.
Additional Skills: Previous research and development with technical industry exposure, experience with statistical analysis tools, and benefit-risk assessments, product development
Computer and Technology Knowledge (Desirable): AutoCAD, MS Windows, Data analysis software, MS Excel, SolidWorks software, Computer-aided design, MS Office
Work Setting: General office, Research institute or laboratory
Benefits: Dental plan, Health care plan, medical plan
Employer and mailing address: Fluid Biomed Inc., 3710 33 St NW, Calgary, Alberta, T2L 1M1
Apply by email:
[email protected]
Only those selected for an interview will be contacted.
How to Apply: candidates must include: Resume with cover letter and references attesting experience
📌 Design Quality Assurance Engineer-In-Training (Calgary)
🏢 Important Business
📍 Calgary