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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 R&D 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: Design and execute bench studies, including preparing protocols, test methods, and reports, to evaluate the mechanical behavior of our neurovascular stent.
  • Coordinate Activities with Suppliers: Coordinate activities with external material suppliers, contract testing and manufacturing providers, including prototyping, evaluation of first articles, fabrication scale up, and equipment procurement.
  • Specify and Source 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: 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: 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.
  • Participate in Prototyping and Investigational Studies: 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: 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 Laboratory/Shop Operations: Hands-on experience with basic laboratory/shop operations.
  • Experience with Biomaterials, Polymers, and/or Metals: Experience with biomaterials, polymers, and/or metals preferred.
  • Strong Technical Writing Skills: Strong technical writing skills to complete documentation in timely fashion.
  • Competence with MS Office Suite Software: Competence with MS Office suite software.

Additional Skills:

  • Excellent Documentation, Communication, Time Management, and Interpersonal Relationship Skills: Excellent documentation, communication, time management, and interpersonal relationship skills.
  • Ability to Adhere to Quality Management Systems Requirements: Ability to adhere to Quality Management Systems requirements (ISO).
  • Ability to Manage Competing Priorities: Ability to manage competing priorities in a fast-paced environment.

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