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Biomedical Engineer

2 months ago

Calgary, Alberta, Canada Fluid Biomed Inc. Full time
Job Summary

Fluid Biomed Inc. is seeking a highly skilled Biomedical Engineer to join our team in the development of a novel implantable medical device. As a key member of our research and development team, you will be responsible for technical reporting, data entry and analysis, product inspection and material testing/evaluation, and participating in R&D activities.

Key Responsibilities
  • Design and Execute Bench Studies: Prepare protocols, test methods, and reports for bench studies, including mechanical behavior of the stent.
  • Coordinate Activities with Suppliers and Providers: Coordinate activities with external material suppliers, contract testing and manufacturing providers, including prototyping, evaluation of first articles, fabrication scale up, etc.
  • Specify, Source, and Install Equipment: 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 and Testing: 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: Plan and conduct Human Factors evaluations, remediate interface challenges for improved ease of use.
  • Perform Products/Materials Inspection: Perform products/materials inspection.
  • Conduct Image Processing and Analysis: 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: Complete and review technical reports to document results and provide traceable evidence per requirements of company Quality Management System.
  • Support Pre-Commercialization Activities: 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: Conduct literature reviews to compile reference information regarding materials, competitor device performance, regulatory standards, etc.
Requirements
  • Education and Experience: 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: Hands-on experience with basic laboratory/shop operations.
  • Technical Skills: 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). Ability to manage competing priorities in a fast-paced environment.