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Senior Process Engineer
2 months ago
Vena Medical is a pioneering medical technology company at the forefront of revolutionizing stroke treatment through cutting-edge catheter-based innovations. Our commitment to innovation has driven the development of our flagship products, the Vena MicroAngioscope and the Vena Balloon Distal Access Catheter. These groundbreaking 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 seeking exceptional talent to join our dynamic team.
Position OverviewWe're looking for a Senior Process Engineer to play a pivotal role in scaling our production capabilities from hundreds to thousands 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.
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, and PPQ.
- Develop manufacturing processes.
- Lead process validation and equipment qualification.
We're seeking a highly experienced professional with a strong background in medical device manufacturing, particularly involving catheters and endoscopes. The ideal candidate will have:
- Extensive experience with catheter, endoscope, or intravascular imaging production.
- A 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.
The successful candidate will possess:
- A 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.
