QUALIFICATIONS

• Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline; or equivalent technical background.
• 5+ years of Quality experience in the regulated medical device industry, with direct hands-on catheter manufacturing and testing experience.
• Proven, practical expertise in ISO 13485 implementation and compliance, plus strong knowledge of FDA 21 CFR Part 820, GMP, and ISO 14971 risk management.
• Experience in process optimization, test method development, equipment validation, and regulatory compliance.
• Proficiency in developing MPIs, work instructions, test methods, protocols, and validation reports.
• Strong organizational and communication skills, with the ability to manage multiple priorities in a dynamic environment.
• Hands-on, startup mentality with a proactive approach to problem-solving and continuous improvement.
• Ability to work cross-functionally to identify and close process gaps.

ABOUT THE ROLE

VahatiCor, a T45 Labs portfolio company, is seeking a highly motivated Quality Engineer with direct catheter device experience and proven ISO 13485 expertise to support the production of groundbreaking medical devices. This is a hands-on role focused on catheter manufacturing, documentation development, process improvement, testing, and risk assessment.

KEY RESPONSIBILITIES

• Develop and maintain Quality System documentation including MPIs, SOPs, work instructions, test methods, protocols (DV), and validation reports.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and ICH guidelines.
• Support combination product regulatory filings and clinical trials (US and OUS).
• Assist in sterile product lot release documentation.
• Participate in internal and external audits, inspections, and supplier quality assessments.
• Partner with R&D, engineering, and manufacturing to integrate quality standards across the product lifecycle.
• Identify and help close gaps in manufacturing and documentation processes.
• Support development and refinement of workflows for manufacturing and testing.
• Assist in the design and implementation of fixtures, tooling, and process improvements to enhance catheter production.
• Conduct root cause analysis and support CAPA implementation to resolve quality issues.
• Contribute to the development and validation of test methods for catheter components and final assemblies.
• Perform risk assessments (FMEA, hazard analysis) to proactively identify and mitigate quality risks.
• Collaborate with R&D, Manufacturing, and Regulatory teams to ensure product quality and reliability.
• Verify that all product releases meet defined quality criteria before market launch.