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Senior Process Engineer

2 months ago

Kitchener, Ontario, Canada Vena Medical Full time
About Us

Vena Medical is a pioneering company at the forefront of revolutionizing stroke treatment through cutting-edge catheter-based technologies.

Our commitment to innovation has inspired our flagship products, the Vena MicroAngioscopeTM and the Vena Balloon Distal Access CatheterTM. These pioneering technologies provide neurointerventional physicians with advanced tools for treating stroke, marking a significant leap forward in medical technology.

We are seeking a highly skilled Senior Process Engineer to join our dynamic team and contribute to the advancement of medical treatments and improving patient's lives.

Job Summary

We are looking for a Senior Process Engineer to lead the scaling of production processes for catheters and endoscopes, ensuring a smooth transition from low to high volume.

The ideal candidate will have extensive experience with catheter, endoscope, or intravascular imaging production, and a proven track record of taking production from 100 units to 1000 units.

Key Responsibilities
  • Manage technical aspects of process validation and development, including balloons, optics, hydrophilic coatings and laser cut hypotubes.
  • Oversee contract manufacturers and suppliers, maintaining strong relationships and ensuring quality compliance.
  • Coordinate the transfer of manufacturing lines in-house, optimizing processes and reducing dependencies.
  • Development of manufacturing processes.
  • Extensive experience with catheter, endoscope, or intravascular imaging production.
  • Proven track record of taking production from 100 units to 1000 units.
  • Experience in design and design for manufacturing.
  • Experience in managing contract manufacturers and suppliers.
  • Experienced in Six Sigma, statistical analysis, solidworks, reflow, laser welding, coiling, braiding, laser cutting, adhesive bonding, balloon bonding, hot boxes and laminators.
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
  • Significant experience in medical device manufacturing, particularly involving catheters and endoscopes.
  • Demonstrated experience in adhering to a ISO 13485 certified quality management system.
  • A proactive and results-oriented approach to projects, with a keen interest in biomedical technology.
Why Join Vena Medical?

Vena Medical is not just a workplace. It's a ground-breaking community where your work directly contributes to the advancement of medical treatments and improving patient's lives.

We offer competitive salaries, comprehensive benefits, flexible work-life balance and a supportive environment that fosters innovation and personal growth.