Design Quality Assurance Engineer-In-Training

Description

Fluid Biomed Inc. requires a full-time Design Quality Assurance Engineer-In-Training in Calgary, Alberta.

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 Environment: 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

How to Apply

Apply by email: kannan@fluidbiomed.com

Only those selected for an interview will be contacted.

How to Apply: candidates must include: Resume with cover letter and references attesting experience

Job Categories: Science. Job Types: Full-Time. Job expires in 60 days.

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