Senior Engineer, Change & Quality Assurance (Medical Devices)

WSA – Wonderful Sound for All

Singapore

Sur place

SGD 90 000 - 120 000

Plein temps

14 jours+

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Résumé du poste

WSA – Wonderful Sound for All is seeking a design/engineering professional to lead end-to-end ECR/ECO processes and manage BOMs and drawings for medical devices. You will verify and validate changes, review DFMEA, and coordinate with cross-functional teams to ensure compliant implementation of new designs.

The role requires 3+ years in R&D or product engineering, proficiency with 3D CAD (Creo/SolidWorks), and experience in ISO 13485 environments.

Qualifications

Minimum 3 years of experience in R&D, Product Design, Process Engineering or Product Engineering.
Experience in medical devices or electro-acoustic products preferred.
Experience with ISO 13485, GMP, FDA regulations or similar','Knowledge of ECR/ECO processes and BOM management.

Responsabilités

Manage end-to-end ECR/ECO process from change initiation to closure and assess impact on BOMs, drawings, and documentation.
Ensure technical assessments, risk evaluations, verification and validation activities are defined and completed per ECM procedures.
Review test plans for qualification of new components, materials, supplier process changes, or design changes.
Review test results and verification/validation data against test plans and address technical issues.
Review and maintain product BOMs, update drawings/specifications, perform DFMEA, manage obsolescence of BOMs and docs.
Collaborate with cross-functional and supply chain teams on old stock disposition and rollout of design changes.