Senior Process Engineer

About Us :

Vena Medical is at the forefront of revolutionizing stroke treatment through cutting-edge catheter-based technologies. Our commitment to innovation has inspired our flagship products, the Vena MicroAngioscope™️ and the Vena Balloon Distal Access Catheter™️.

These pioneering technologies provide neurointerventional physicians with advanced tools for treating stroke, marking a significant leap forward in medical technology.

As we continue to expand our product line and impact on the medical community, we're looking for exceptional talent to join our dynamic team.

The Vena MicroAngioscope™️ is providing physicians with a new set of eyes, the world’s smallest camera that delivers a live imaging-feed from inside veins and arteries to help them treat stroke.

The Vena Balloon Distal Access Catheter™️ has combined both a distal access catheter and balloon guide catheter into one, bringing the balloon closer to the clot, reducing residual clots, increasing first-pass success rate, and cutting costs.

Position :

Senior Process Engineer

Location :

Hybrid Office in Kitchener, Ontario, Canada

Role Overview :

Join us as a Manufacturing Process Engineer, where you will play a pivotal role in scaling our production capabilities from 100’s of units to 1000’s of units, increasing patients access to life changing medical devices.

You will be instrumental in process validation, development, and overseeing the technical transfer of manufacturing lines in-house and at contract manufacturers while working directly with the founders of Vena Medical.

We’re open to senior and intermediate level candidates.

Key Responsibilities :

• Lead the scaling of production processes for catheters and endoscopes, ensuring a smooth transition from low to high volume.
• 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.
• Complete process validation for new processes and products including IQ, OQ, PQ & PPQ.
• Development of manufacturing processes
• Lead process validation and equipment qualification

Ideal Candidate Profile :

• 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.
• Strong background in process validation and development of catheters or endoscopes.
• Experience in managing contract manufacturers and suppliers.
• Knowledgeable in hydrophilic coatings and laser cut hypotubes.
• Experienced in Six Sigma, statistical analysis, solidworks, reflow, laser welding, coiling, braiding, laser cutting, adhesive bonding, balloon bonding, hot boxes and laminators.

Qualifications :

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Significant experience in medical device manufacturing, particularly involving catheters and endoscopes.
• Demonstrated ability to develop validation and verification workflows for process and design changes
• Demonstrated experience in adhering to a ISO 13485 certified quality management system.
• Excellent communication skills, both verbal and written, with demonstrated leadership abilities.
• 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.

If you're looking to make a tangible difference in the medical field, join us in paving the way for the future of neurointerventional procedures.