Design Assurance Engineer II

Design Assurance Engineer II

Published on:
Sep 8, 2026

Country:
United States

Location:

Austin, Texas

Company:
Luminex Corporation

Job Category:
Quality

Employment type:

Regular Full Time

Req

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

• Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development.

The Design Assurance Engineer II acts as the quality representative on design core teams for electromechanical instruments, reagents and assays for the life science and in-vitro diagnostics market. Design Assurance Engineer II is responsible for guiding the development teams through the Design Control process ensuring compliance with FDA, ISO, QSR, quality, safety and environmental regulations and internal procedures. Design Assurance Engineer II may also provide support for quality initiatives, post market design changes/improvements and quality surveillance activities.

• Participates on design core teams utilizing experience to guide team members through the Design Control processes to achieve business, operational, quality, regulatory, and safety goals for new products.
• Assists team members in the creation and maintenance of design deliverables (Design & Development Plans, Inputs/Outputs, Protocols, Matrices, etc) are ensures they are completed on-time and per regulations.
• Guides the risk management process for design teams through the creation of risk documents ensuring all risks are appropriately identified, mitigated and verified.
• Recommends rationale, including statistical tools, for protocol structure.
• Acts as a resource within and cross departmental for design control related questions & challenges
• Develops and implements quality system improvements within the design processes.
• Supports quality system training and participates in the development of training programs
• Other duties as assigned.

• Bachelor's Degree in a life science/engineering discipline required
• 5+ Years Experience in regulated environment required, previous design assurance experience required
• 1+ Years Experience in an Good Manufacturing Practices (GMP) environment required, preferably in medical device industry required
• 1+ Years Experience as a member of a design team required
• 1+ Years Working knowledge of current industry quality practices under QSRs, ISO-13485 and international regulations preferred
• 1+ Years Experience with medical device risk management (ISO 14971) is preferred
• 1+ Years Experience with usability (ISO 62366) is preferred
• Excellent interpersonal, verbal and written communication skills
• Certification in a quality…