Design Quality Engineer

Job Description

Design Assurance Engineer (Software / Digital Quality) — Job Description

Travel Requirement: Up to 20%

The Design Assurance Engineer is responsible for ensuring that software and digital products developed in regulated environments meet defined quality, safety, and compliance standards throughout the product lifecycle. The role partners with new product development (NPD) teams to ensure adherence to global regulatory requirements, risk management practices, and verification and validation strategies.

Key Responsibilities

Design Quality & Compliance

Own and execute risk management activities in alignment with ISO 14971.

Ensure compliance with medical device software lifecycle processes (IEC 62304).

Review Design Inputs, Design Outputs, and Design History File (DHF) documentation.

Ensure compliance with product security, safety, and effectiveness requirements.

Software Quality Assurance

Ensure software development processes comply with defined lifecycle standards.

Review test plans, test logs, verification & validation (V&V) artifacts.

Support defect analysis and ensure proper tracking and closure.

Participate in architecture and, where applicable, code-level reviews.

Development & Cross-Functional Support

Collaborate with R&D, Regulatory, Testing, and Post-Market Quality teams.

Support development of software architecture aligned with regulatory expectations.

Define and review requirements, system design, and test strategies.

Contribute to verification and validation planning for complex systems.

Design Reviews & Risk Management

Conduct and moderate design reviews across multiple phases of NPD.

Drive risk management methodologies for complex software systems.

Ensure alignment between software, hardware, and systems engineering practices.

Process Improvement & Training

Promote quality engineering best practices across teams.

Improve documentation, traceability, and formal review processes.

Educate teams on regulatory standards and quality system requirements.

Qualifications

Minimum Requirements

Bachelor's degree in Computer Science, Software Engineering, Electronics, or related field.

4–8 years of experience in software quality engineering or new product development.

Required Knowledge & Experience

Hands-on experience with medical device software lifecycle (IEC 62304).

Strong understanding of ISO 14971, ISO 13485, 21 CFR 820, and related regulatory standards.

Experience in software verification, validation, and quality assurance in NPD environments.

Familiarity with Quality Management Systems in regulated industries.

Preferred Skills

Basic understanding of programming languages and embedded systems.

Experience in defect review and software lifecycle tools.

Strong exposure to system-level requirements, architecture, and test design.

Experience conducting formal design reviews (SRS, architecture, code reviews).

Ability to work across multidisciplinary engineering teams.

Strong communication and documentation skills.