Manufacturing Process Engineer
1 week ago
We are seeking an experienced Manufacturing Process Engineer to join our team at Fluid Biomed Inc. in Calgary, Alberta.
About the RoleThis is a unique opportunity to advance the development of a novel implantable medical device and ensure its readiness for human use.
About UsFluid Biomed Inc. is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.
Responsibilities- 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.
- Study existing processes to implement improvements on new products.
- 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.
- Document and execute equipment/process validation protocols & reports.
- Lead and provide guidance to team members, with potential responsibilities for team leadership.
- Drive DFM/A and future design decisions by data-driven interactions across the entire value stream (component, sub-assembly, final assembly).
- Lead robust design transfer strategy from development throughout product commercialization phases to ensure scalability from day 1 of launch.
- 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 streamline various processes, including 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 Bachelor's 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 (SolidWorks), GD&T, Process Simulation, Failure Analysis Techniques (Fault tree, Fish Bone Diagram).
- The ability to influence others to achieve business objectives, and excellent written and oral communication skills.
- Experience in a regulated industry; medical device experience is a plus.
- Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services.
- Technical writing to include protocols, testing results, procedures, project status, and special reports.
- Experience in managing product, project, and process risks.
- Knowledge of computer programs in addition to Microsoft Office products.
- Self-starter with a proven track record to engage in proactive learning and remain productive with minimal direction.
- Must be highly organized with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
- Experience in process/product validations.
- Hands-on experience with basic laboratory/shop operations.
- Strong technical writing skills to complete documentation in a timely fashion.
- Prior leadership experience in managing a team of any capacity.
Calgary, Alberta, Canada
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