Senior Design Assurance Engineer

Senior Design Assurance Engineer

SGD 6,000 – 8,000/month

We are partnering with an established medical device manufacturer to hire a Senior Design Assurance Engineer to support new product development and sustaining engineering activities within a regulated medical device environment.

Key Responsibilities

• Serve as the Design Quality representative for new product development and sustaining projects

• Lead and facilitate Design Control and Risk Management activities throughout the product lifecycle

• Drive Design Verification & Validation (V&V), process validation, usability studies, and test method validation

• Conduct risk assessments including Hazard Analysis, Risk-Benefit Analysis, dFMEA, and pFMEA

• Ensure compliance with ISO 13485, ISO 14971, FDA QSR, and applicable regulatory requirements

• Develop and maintain quality document...