Design Quality Assurance Engineer II - Medical Devices

Boston Scientific; Kuala Lumpur; Presencial; MYR 90 000 - 120 000; Tempo integral

Resumo da oferta

Boston Scientific seeks a Design Assurance Engineer II in Penang to influence design strategy, risk management and lifecycle quality across medical devices. You will collaborate with R&D, manufacturing, regulatory and clinical teams to ensure patient safety and product excellence.

You will lead verification and validation planning, maintain Design History Files, and support cross-functional teams through the product lifecycle in a fast-paced, global environment.

Qualificações

• Bachelor of Science degree in engineering or related technical field.
• Minimum of 3 years' experience in quality engineering or design assurance within the medical device industry.
• Expertise in risk management, design controls and product verification/validation.
• Strong knowledge of ISO 13485 and ISO 14971.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsabilidades

• Support systematic problem-solving to resolve complex product and process quality issues across the lifecycle.
• Provide quality engineering assessment for new product development with robust design inputs and verification/validation strategies.
• Drive risk management activities including hazard analysis, FMEA and alignment with ISO standards.
• Develop verification and validation protocols and reports per global regulatory requirements.
• Establish and maintain Design History File documentation (requirements, specs, outputs).
• Lead design change control activities and assess product/process impacts while ensuring patient safety.
• Monitor field performance and drive CAPAs as needed.

Conhecimentos

Quality engineering

Design assurance

Risk management

Regulatory compliance

Cross-functional collaboration

Formação académica

Bachelor of Science in Engineering

Ferramentas

FMEA

Statistical methods

Descrição da oferta de emprego

Boston Scientific seeks a Design Assurance Engineer II in Penang to influence design strategy, risk management and lifecycle quality across medical devices. You will collaborate with R&D, manufacturing, regulatory and clinical teams to ensure patient safety and product excellence.

You will lead verification and validation planning, maintain Design History Files, and support cross-functional teams through the product lifecycle in a fast-paced, global environment.