Manufacturing Engineering

1 week ago

Calgary AB, Canada Fluid Biomed Inc. Full time

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.
Coordinate activities with external material suppliers 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 and delivery system processes using Failure Modes and Effects Analysis (FMEA) methodology and execute follow-up testing required to provide evidence of mitigation.
Complete and review technical reports to document results and provide traceable evidence per requirements of company Quality Management System.
Partner with R&D, Quality, Manufacturing, Regulatory and other cross functional partners to complete manufacturing improvement projects to enhance process capability, maintainability, instrument assembly capability, or instrument output performance.
Drive DFM/A and future design decisions by data driven interactions across entire value stream (component, sub-assembly, final assembly).
Lead end to end process solution deployment, from feasibility to verification/validation, including creating fixturing/tooling for Manufacturing & Assembly processes.
Explore, design and drive technology, equipment and process selection and deployment of automation solutions to stream-line various processes: including, but not limited to braiding, mandrel preparation, laser welding, extrusions, tipping, soldering, metal wire grinding, injection molding, final inspection, and pouching/boxing/label printing processes.

A minimum of 3-5 years of related working experience.
A minimum of a Bachelors degree in an Engineering field
Knowledge of good manufacturing practices and documentation.
Knowledge of a combination of process engineering tools such as DOE’s, Statistical Methods, CAD (Solid-works), GD&T, Process Simulation, Failure Analysis Techniques (Fault tree, Fish Bone Diagram).
medical device experience is a plus.
Technical writing to include protocols, testing results, procedures, project status & special reports
Experience in managing product, project, and process risks
Knowledge of computer programs in addition to Microsoft office products.
Must be highly organized with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks
Strong technical writing skills to complete documentation in timely fashion.
Ability to adhere to Quality Management Systems requirements (ISO 13485).
· Experience in the development of medical devices
Experience in quality engineering activities such as FMEA, CAPA, and NC
Knowledge of In Process Control acceptance
Effective team interpersonal skills, along with conflict analysis & resolution experience

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

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