Design Assurance Engineer II - Medical Devices & Risk

Boston Scientific Gruppe; Penang; On-site; MYR 60,000 - 110,000; Full time

Job summary

Boston Scientific Gruppe in Penang, Malaysia, seeks a Design Assurance Engineer II to support commercialized medical devices and enhance patient care globally. You will influence design strategy, risk management, and lifecycle quality activities while partnering with cross-functional leaders in R&D, manufacturing, regulatory, and clinical.

This role is on-site in Penang and offers collaboration across global teams in a high-performance culture that values continuous learning and meaningful

Qualifications

• 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.
• Demonstrated expertise in risk management, design controls and product verification and validation.
• Strong knowledge of global quality system regulations and standards, including 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

Problem solving

Communication skills

Quality engineering

Design assurance

Risk management

Education

Bachelor of Science degree in Engineering or related field

Tools

ISO 13485

ISO 14971

Job description

Boston Scientific Gruppe in Penang, Malaysia, seeks a Design Assurance Engineer II to support commercialized medical devices and enhance patient care globally. You will influence design strategy, risk management, and lifecycle quality activities while partnering with cross-functional leaders in R&D, manufacturing, regulatory, and clinical.

This role is on-site in Penang and offers collaboration across global teams in a high-performance culture that values continuous learning and meaningful