Design Assurance Engineer II — Medical Devices

Boston Scientific; Seberang Perai; On-site; MYR 120,000 - 180,000; Full time

Job summary

Boston Scientific in Penang, Malaysia is seeking a Design Assurance Engineer II to influence design strategy, risk management and lifecycle quality activities across cross-functional teams including R&D, manufacturing, regulatory and clinical.

This on-site role requires a BS in Engineering, 3+ years of medical device quality experience, strong knowledge of ISO 13485/14971, and excellent written and spoken communication. Relocation assistance available; sponsorship not provided.

Qualifications

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

Responsibilities

• Support systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle.
• Provide quality engineering assessment on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance.
• Drive the implementation and continuous improvement of risk management activities, including hazard analysis, fault tree analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards.
• Develop verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
• Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.
• Core team member of design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
• Monitor field performance of new and established medical devices, analyze trends against risk assessments and drive corrective and preventive actions as needed.

Skills

Communication skills

Cross-functional collaboration

Prioritization

Education

Bachelor of Science in Engineering

Job description

Boston Scientific in Penang, Malaysia is seeking a Design Assurance Engineer II to influence design strategy, risk management and lifecycle quality activities across cross-functional teams including R&D, manufacturing, regulatory and clinical.

This on-site role requires a BS in Engineering, 3+ years of medical device quality experience, strong knowledge of ISO 13485/14971, and excellent written and spoken communication. Relocation assistance available; sponsorship not provided.