This is a unique opportunity to join the quality engineering team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide. The Quality Design Assurance Engineer will lead and participate in design control and risk management activities for new product development projects at Fluid Biomed. The Quality Design Assurance Engineer will work in a fast paced and dynamic environment where leadership skills, taking initiatives and collaborating cross-functionally are critical for success. The ideal candidate is a self-directed learner who quickly absorbs and adapts to the current business need, anticipates change, willingly seeks out additions to their “tool kit” and delights in overcoming barriers and finding creative solutions to complex problems.

Key Responsibilities:

• Apply quality and compliance (ISO 13485 and applicable regulatory requirements such as FDA 21 CFR Part 820) knowledge to provide design assurance support throughout the product development lifecycle
• Support the technical team in the development and review of Design History File (DHF) documents including Design Inputs, Design Outputs, Design Verification & Validation Plans, Test Methods, Usability Testing, etc.
• Perform risk management activities in compliance with ISO 14971 and ensure risk controls and mitigations are effectively implemented
• Participate in design/technical reviews to ensure adherence to quality and regulatory requirements
• Conduct risk reviews in association with the design reviews throughout the design control process
• Support technical team in developing and executing design verification and validation (V&V) test plans, protocols, and reports, including the determination of acceptance criteria, and risk-based sampling plan
• Ensure proper documentation of design change activities and conduct appropriate impact and risk assessments
• 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 and reporting
• Support quality assurance with internal and external regulatory audit activities
• Assist with other quality engineering and quality control activities as required.

Education and Experience Requirements:

• Bachelor’s degree in engineering or science or equivalent
• Minimum 2 years’ experience in medical device, biotech or pharmaceutical industry
• Design control, change and risk management experience in a medical device company (ISO 13485)
• Demonstrated experience with Failure Modes and Effects Analysis (FMEA) and ISO 14971
• Demonstrated experience with non-conformity and corrective/preventive action (CAPA) activities.

Additional Skills:

• Previous R&D/technical industry exposure, able to understand company technology at a practical level
• Hands-on experience with design verification and validation (V&V) protocols and testing preferred
• Experience with statistical analysis tools (Minitab, JMP, or equivalent)
• Excellent documentation, communication, and interpersonal relationship skills
• Strong problem-solving, organizational, analytical, and critical thinking skills
• Ability to navigate uncertainty/fluidity in role scope, priorities, and timelines
• Ability to manage competing priorities in a fast-paced and dynamic environment
• Proven expertise in usage of MS Office Suite.

Role is on-site in Calgary, AB and candidates must be legally entitled to work full time in Canada.