Design Quality Engineer – Medical Device Software

The Davis Companies; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

The Davis Companies is seeking a Design Quality Engineer to join a growing medical device team focused on Class III products. You will act as a quality representative for sustaining and new product development, partnering with Engineering, Manufacturing, Software, and Regulatory to ensure FDA and ISO 13485 compliant development.

The ideal candidate has experience with design controls, risk management, design reviews, V&V, and software quality in a regulated medical device environment.

Qualifications

• Design controls knowledge required for regulated medical devices.
• Experience with risk management per ISO 14971 and FDA QMSR.
• Hands-on design quality in Class III medical devices.
• Familiarity with design reviews, V&V, and software quality per IEC 62304.

Responsibilities

• Lead design change assessments and participate in change control.
• Support CAPA investigations and nonconformance activities.
• Contribute to risk management activities and design transfer.
• Assist in process validation and driving continuous improvement.

Skills

Design controls

Risk management

Engineering changes

Software quality

Design reviews

Verification & validation

CAPA investigations

Nonconformance

Process validation

Design transfer

Continuous improvement

FMEA

Risk assessments

Software development lifecycle

Statistical analysis

Tools

Minitab

Job description

The Davis Companies is seeking a Design Quality Engineer to join a growing medical device team focused on Class III products. You will act as a quality representative for sustaining and new product development, partnering with Engineering, Manufacturing, Software, and Regulatory to ensure FDA and ISO 13485 compliant development.

The ideal candidate has experience with design controls, risk management, design reviews, V&V, and software quality in a regulated medical device environment.