Design Software Quality Engineer

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

We're looking for a Design Quality Engineer to join a growing medical device team focused on developing and supporting innovative Class III products. In this role, you'll serve as a key quality representative for both sustaining and new product development activities, partnering closely with Engineering, Manufacturing, Software, and Regulatory teams to ensure products are developed and maintained in compliance with FDA and international quality standards.

The ideal candidate will have experience with design controls, risk management, engineering change orders, and software quality within a regulated medical device environment. You'll lead design change assessments, support risk management activities in accordance with ISO 14971, participate in design reviews, verification and validation efforts, and help drive software quality activities aligned with IEC 62304. This position will also support CAPA investigations, nonconformance activities, process validation, design transfer, and continuous improvement initiatives.

Qualified candidates will have hands on Design Quality experience within the medical device industry. Experience with Class III devices, FMEA, risk assessments, software development lifecycle processes, Minitab, statistical analysis, and quality system regulations including FDA QMSR and ISO 13485 is highly preferred. Strong communication skills and the ability to collaborate across cross functional teams are essential for success in this role.