QUALIFICATIONS

• Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline; or equivalent technical background.
• 5+ years of experience in Quality within a regulated medical device industry (catheter or vascular device experience preferred).
• Minimum 2 years in a management/leadership role overseeing QA or Quality Engineering teams.
• Proven expertise with ISO 13485, FDA 21 CFR Part 820, GMP, and ISO 14971 risk management.
• Strong track record in process optimization, test method development, equipment validation, and regulatory compliance.
• Proficiency in developing MPIs, work instructions, test methods, protocols, and validation reports.
• Excellent leadership, 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.

ROLE SUMMARY

VahatiCor, a T45 Labs portfolio company, is seeking a highly motivated Quality Engineer to support the production of groundbreaking medical devices. This position is both strategic and hands-on, requiring leadership of the QA team, as well as expertise and direct involvement in catheter manufacturing, documentation development, process improvement, and risk assessment. This role will be responsible for creating and maintaining documents within our Quality System, including: Manufacturing Process Instructions (MPIs), work instructions, test methods, design verification (DV) protocols, and reports. The candidate will play a hands-on role in improving manufacturing workflows, developing fixtures, identifying process gaps, and optimizing testing procedures. The ideal candidate will thrive in a fast-paced startup environment, be an effective cross-functional collaborator, and have the entrepreneurial drive to make a measurable impact on patient lives.