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Senior Process Engineer
2 months ago
Vena Medical is a pioneering company in the field of neurointerventional procedures, revolutionizing stroke treatment with cutting-edge catheter-based technologies. Our commitment to innovation has led to the development of groundbreaking products, including the Vena MicroAngioscopeTM and the Vena Balloon Distal Access CatheterTM. These innovative technologies provide neurointerventional physicians with advanced tools for treating stroke, marking a significant leap forward in medical technology.
Role OverviewWe are seeking a highly skilled Manufacturing Process Engineer to join our dynamic team. As a key member of our production team, you will 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 responsible for process validation, development, and overseeing the technical transfer of manufacturing lines in-house and at contract manufacturers.
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.
We are looking for a highly experienced Manufacturing Process Engineer with a strong background in medical device manufacturing, particularly involving catheters and endoscopes. The ideal candidate will have a proven track record of taking production from 100 units to 1000 units, experience in design and design for manufacturing, and a strong understanding of process validation and development.
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.
