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This is a unique opportunity to join an early-stage company to further the development of a novel implantable medical device and ensure its readiness for human use. The Biomedical Engineer Stent Line will lead both analytical and hands-on activities to evaluate, optimize and prepare devices for clinical use and regulatory approval. The incumbent will work in a fast paced and dynamic environment, where taking initiative 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 his/her “tool kit” and delights in overcoming barriers and finding creative solutions to complex problems.

Key Responsibilities:

·      Design and execute bench studies focused on the mechanical behaviour (tensile, torsion, shear, fatigue, compression, radial force, simulated use) of intracranial stent

·      Coordinate activities with external material suppliers, contract testing and manufacturing providers including prototyping, evaluation of first articles, fabrication scale up, qualification of manufacturing lines, 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

·      Apply engineering principles and clinician input to optimize design of stent, source or create CAD models and prototypes for demonstration and evaluation

·      Plan and conduct Human Factors evaluations, remediate interface challenges for improved ease of use

·      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.

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)

·      Experience working in ISO 13485 certified organization or with standard requirements preferred

·     Demonstrated experience with testing, design/modeling software and prototype creation and evaluation

·      Experience with relevant development equipment (microscopes, braiders, microwelding, 3D printing, typical shop equipment) strongly preferred.

Additional Skills:

·      Hands-on experience with implants, cleanroom manufacturing processes and bench testing desired

·      Strong technical engineering skills, able to understand device design and function at a practical level

·      Strong knowledge of mechanical testing including equipment qualification, calibration and operation

·      Excellent documentation, communication and interpersonal relationship skills

·      Working knowledge and understanding of modeling (FEA) and statistical techniques and related software

·      Strong problem-solving, organizational, analytical and critical thinking skills

·      Ability to navigate uncertainty in project scope, timelines, and requirements.

Role will be located in person in Calgary, AB and candidates must be legally entitled to work full time in Canada.