Biomedical Engineer

Role Description

This is a unique opportunity to join an early-stage company to advance the development of a novel implantable medical device, ensuring its readiness for human use.

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 biomedical engineer will be responsible for technical reporting, data entry and analysis, product inspection and material testing / evaluation as well as participating in R&D activities.

The Biomedical Engineer will work in a fast paced and dynamic environment where collaborating cross-functionally is critical for success.

Key Responsibilities :

• Design and execute bench studies (including preparing protocols, test methods, reports); for example on the mechanical behaviour of the stent.
• Coordinate activities with external material suppliers, contract testing and manufacturing providers including prototyping, evaluation of first articles, fabrication scale up, etc.
• Specify, source, procure, install, qualify, and calibrate equipment required to support the manufacturing, testing, processing and storage of components and product.
• Participate in risk evaluation on stent design and process using Failure Modes and Effects Analysis (FMEA) methodology and execute follow-up testing required to provide evidence of mitigation.
• Plan and conduct Human Factors evaluations, remediate interface challenges for improved ease of use.
• Perform products / materials inspection.
• Conduct image processing of microscope and / or medical images (angiograms, CT and MRI scans) and use or create programming code to automate analysis where appropriate.
• Complete and review technical reports to document results and provide traceable evidence per requirements of company Quality Management System.
• Support additional pre-commercialization activities including verification of product shelf life, development of packaging, and assessment of impact of storage and shipping of product.
• Conduct literature reviews to compile reference information regarding materials, competitor device performance, regulatory standards, etc.
• In general, to participate in prototyping and investigational studies as well as V&V and R&D activities for existing and next generation devices.

Education and Experience Requirements :

• Relevant Bachelor's Degree in Engineering + minimum of 1 year experience in medical device industry (exceptional new graduates with design or manufacturing exposure will be considered)
• Hands-on experience with basic laboratory / shop operations.
• Experience with biomaterials, polymers and / or metals preferred.
• Strong technical writing skills to complete documentation in timely fashion.
• Competence with MS Office suite software.

Additional Skills :

• Excellent documentation, communication, time management, and interpersonal relationship skills.
• Ability to adhere to Quality Management Systems requirements (ISO 13485).
• Ability to manage competing priorities in a fast-paced environment.

Role will be located physically on-site in Calgary, Alberta and candidates must be legally entitled to work full-time in Canada.