Design Assurance Engineer II

DiaSorin; Austin (TX); On-site; USD 95,000 - 130,000; Full time

Job summary

Diasorin is seeking a Design Assurance Engineer II to join our Austin campus. You will act as the quality representative on design core teams for electromechanical instruments and assays, ensuring compliance with FDA, ISO, QSR and related regulatory requirements throughout the design control lifecycle.

Ideal candidates hold a bachelor's in life sciences or engineering, 5+ years in regulated environments, GMP experience, and familiarity with risk management and quality improvements.

Qualifications

• Bachelor's degree in life science or engineering required.
• 5+ years experience in regulated environment.
• 1+ years GMP environment experience preferred.
• Experience as a member of a design team.
• Familiarity with QSR, ISO-13485 and international regulations preferred.

Responsibilities

• Act as quality representative on design core teams for electromechanical instruments and assays.
• Guide design control processes to meet regulatory requirements.
• Develop and maintain design deliverables and risk documents.
• Contribute to quality system improvements and training programs.
• Support post-market design changes and quality surveillance.

Skills

Communication skills

Problem solving

Statistical tools

Time management

Education

Bachelor's degree in life science/engineering

Tools

Oracle

Windows & Office

Job description

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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

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.

Why Join Diasorin

• 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.

Job Scope

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.

Job Responsibilities and Duties

• 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.

Education, Experience and Qualifications

• 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 discipline preferred, such as CQM, CQA, CQE, etc.
• Strong computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred
• High degree of problem solving and analytical skills
• Ability to apply statistical tools
• Strong organizational and time-management skills

Standard Working Conditions

• Occasional work on-site at Diasorin's Austin campus
• Possible exposure to Chemicals, Lasers, Excessive Noise, etc. - Frequently

Travel Requirements

• 20% Travel may be required; internationally

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail] .