Design Assurance Engineer II - Medical Devices

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

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.