Design Assurance Engineer II — Regulated Medical Devices

DiaSorin; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Diasorin in Austin, Texas is seeking a Design Assurance Engineer II to lead design control activities on electromechanical instruments and assays. You will guide development teams to meet FDA, ISO, QSR requirements and support post-market improvements.

The role requires a life science or engineering degree, 5+ years in a regulated setting, GMP experience, and familiarity with ISO 13485 and ISO 14971. On-site presence and travel may be needed.

Qualifications

• Bachelor's Degree in life science/engineering required.
• 5+ years in regulated environment required; design assurance experience required.
• 1+ year GMP experience; medical device industry preferred.
• Experience as a member of a design team.
• Familiarity with QSRs, ISO-13485 and international regs preferred.
• Experience with ISO 14971 and ISO 62366 preferred.

Responsibilities

• Lead design core teams through Design Control to meet quality, regulatory and safety goals.
• Create and maintain design deliverables and ensure on-time per regulations.
• Guide risk management and produce risk documentation for mitigation and verification.
• Support quality system improvements and training programs.
• Collaborate cross-departmentally on design control questions and challenges.
• Perform other duties as assigned.

Skills

Excellent communication

Problem solving

Analytical skills

Statistical tools

Time management

Education

Bachelor's degree in life science/engineering

Quality discipline certification (CQM/CQA/CQE)

Tools

Oracle

Microsoft Office

Job description

Diasorin in Austin, Texas is seeking a Design Assurance Engineer II to lead design control activities on electromechanical instruments and assays. You will guide development teams to meet FDA, ISO, QSR requirements and support post-market improvements.

The role requires a life science or engineering degree, 5+ years in a regulated setting, GMP experience, and familiarity with ISO 13485 and ISO 14971. On-site presence and travel may be needed.