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Biomedical Engineer

2 months ago

Calgary, Canada Fluid Biomed Inc. Full time

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.