Position Details
About this role
This role leads design quality excellence and regulatory compliance across the product development lifecycle for the Endoscopy Division. You will drive risk management deliverables under ISO 14971 and execute core quality deliverables for new product development, sustaining, and life cycle management.
Key Responsibilities
- Serve as primary quality representative on cross-functional teams
- Lead execution of design quality deliverables (plans, design changes, usability validation plans)
- Drive ISO 14971 risk management deliverables focusing on patient safety
- Lead complex problem-solving using 5 Whys, Is-Is Not, DMAIC, and Six Sigma
- Provide technical leadership, mentorship, and quality system guidance across programs
Technical Overview
The technical scope is quality engineering for medical device design, including execution of Project Design & Development Plans and Design & Usability Validation Plans. It emphasizes patient safety risk management in compliance with ISO 14971 and structured problem-solving using tools like 5 Whys, DMAIC, and Six Sigma.
Ideal Candidate
The ideal candidate is a senior/lead design quality engineering professional who can own quality excellence and regulatory compliance across the product development lifecycle. They have strong experience with ISO 14971 risk management deliverables, executing design quality plans (including design and usability validation), and leading structured problem-solving such as 5 Whys, DMAIC, and Six Sigma.
Must-Have Skills
Required Skills
Hard Skills
Soft Skills
Industry & Role
Clearance & Visa
Keywords for Your Resume
Deal Breakers
Must be able to work in the Austin, TX office at least three days per week (hybrid requirement), Must be able to execute Risk Management deliverables in compliance with ISO 14971
Get matched to jobs like this
Luna finds roles that fit your skills and career goals — no endless scrolling required.
Create a Free Profile