Job Description

Role Overview:

The Design Assurance Engineer ensures that all design activities meet applicable regulatory, customer, and internal standards. This role is pivotal in managing design integrity, certification readiness, and configuration control across the product lifecycle. The engineer will work closely with design, manufacturing, and compliance teams to ensure seamless integration of design assurance into project delivery.

Key Responsibilities:

1. Configuration & Version Control:

Manage part and assembly version rollovers for minor updates to mitigate compatibility issues and ensure traceability across design iterations Maintain configuration baselines and ensure alignment with BOM and design documentation.

2. Certification & Compliance:

Provide support to the design team in achieving EU CE product certification, including technical file compilation and conformity assessment. Determine and document the certification status of COTS components and internally manufactured parts, ensuring all items meet regulatory and customer requirements Collate supporting evidence and produce compliance declarations in line with internal quality procedures and external standards

3. Documentation & Evidence Management:

Modernise and maintain and update the Bill of Materials (BOM), ensuring consistency across systems and suppliers

4. Quality & Non-Conformance Management:

Identify and control non-conforming outputs in accordance with the Quality Management System (QMS), including segregation, correction, and concession management. Ensure all corrective actions are documented and verified for effectiveness.

5. Stakeholder Engagement:

Collaborate with internal teams (e.g. Systems, Mechanical, Electrical) and external suppliers to ensure design assurance requirements are understood and met. Participate in design reviews, audits, and certification meetings.

Qualifications & Experience:

Degree in Engineering or related discipline. Experience in regulated industries (e.g. Defence, Aerospace, Medical Devices). Familiarity with CE marking, ISO 9001, and relevant product safety directives. * Proficiency in configuration management tools and PLM systems.