Senior R&D Technician - Catheter Manufacturing | Route 92 Medical
Overview
You will own the construction and testing of catheter prototypes for neurovascular intervention devices, targeting a zero-defect level at Route 92 Medical. Working with a collaborative engineering team in San Mateo, you will drive in-house manufacturing processes and support FDA-regulated QSR compliance. This role stands out by combining hands-on prototype development with direct impact on human-use builds for life-saving medical devices.
What You'll Do8
- 1Build working catheter prototypes and specifications with engineering teams to achieve zero-defect targets.
- 2Establish in-house manufacturing processes for new and existing products, including training operators at contract manufacturer sites.
- 3Contribute to device production for verification, validation, and human-use builds following GMP standards.
- 4Conduct product testing using Instron equipment and maintain accurate test data sheets.
- 5Troubleshoot manufacturing issues independently and implement corrective actions.
- 6Document materials, parts, processes, and designs for engineering and QSR compliance.
- 7Provide technical feedback on product revisions to project engineers and support product transfers to manufacturing.
- 8Maintain a clean, safe, and organized work area adhering to company policies and FDA regulations.
Requirements8
- 14+ years as an R&D Technician in the medical device industry.
- 2Experience with standard catheter manufacturing processes including hot boxes, UV bonding, and laminators.
- 3Proficiency with Microsoft Word and ability to read engineering drawings.
- 4AA degree in a technical field preferred.
- 5Experience with Instron product testing is a plus.
- 6High school diploma or equivalent.
- 7Ability to work in a certified clean room environment.
- 8Knowledge of QSR and FDA regulations.
Salary Insight
$98 - $119k per year
Location
Required Skills
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