Manufacturing Process Improvement Engineer

1 week ago

Calgary, Alberta, Canada Fluid Biomed Inc. Full time

At Fluid Biomed Inc., we are seeking a talented Manufacturing Process Improvement Engineer to join our team in Calgary, Alberta. As a key member of our manufacturing team, you will play a critical role in driving process improvements and ensuring the highest quality standards for our innovative medical devices.

Job Summary:

We are looking for a highly skilled and motivated individual with a strong background in process engineering and manufacturing to lead process improvements and ensure compliance with regulatory requirements. The successful candidate will have a proven track record of implementing efficient and effective processes, collaborating with cross-functional teams, and communicating complex ideas effectively.

About Us:

Fundamental to our mission is advancing the development of novel implantable medical devices that improve patient outcomes worldwide. Our cutting-edge neurovascular stent is designed to treat brain aneurysms, and we are committed to delivering high-quality products that meet or exceed customer expectations.

Key Responsibilities:
  • Develop and implement process improvements to enhance efficiency, reduce costs, and increase product quality
  • Collaborate with external material suppliers and manufacturing providers to ensure timely delivery of materials and components
  • Specify, source, procure, install, qualify, and calibrate equipment required for manufacturing, testing, processing, and storage of components and products
  • Analyze existing processes to identify opportunities for improvement and develop strategies to implement changes
  • Participate in risk evaluation using Failure Modes and Effects Analysis (FMEA) methodology and execute follow-up testing to provide evidence of mitigation
  • Complete and review technical reports to document results and provide traceable evidence per company Quality Management System requirements
  • Partner with R&D, Quality, Manufacturing, Regulatory, and other cross-functional partners to complete manufacturing improvement projects
  • Document and execute equipment/process validation protocols and reports
  • Lead and guide team members, with potential responsibilities for team leadership
Requirements:
  • A minimum of 3-5 years of related working experience in process engineering and manufacturing
  • A minimum of a Bachelor's degree in an Engineering field (e.g., Mechanical, Electrical, Chemical)
  • Knowledge of good manufacturing practices and documentation
  • Knowledge 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, preferably in medical device development
  • Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services
  • Technical writing skills, including protocols, testing results, procedures, project status, and special reports
  • Experience in managing product, project, and process risks
  • Knowledge of computer programs beyond Microsoft Office products
  • A self-starter with a proven track record of engaging in proactive learning and remaining productive with minimal direction
Preferred Skills & Experience:
  • Experience in medical device development and quality engineering activities such as FMEA, CAPA, and NC
  • Knowledge of In-Process Control acceptance
  • Knowledge of ISO and cGMP regulations
  • Certification in Process Excellence (Green Belt or Black Belt)
  • Effective team interpersonal skills and conflict analysis and resolution experience
Compensation Package:

We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience, plus benefits and opportunities for career growth and professional development.

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