Design Quality Assurance Engineer

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

Job summary

Boston Scientific Malaysia is recruiting a Design Assurance Engineer II to apply engineering expertise across the lifecycle of our medical devices and patient safety initiatives. This on-site role in Penang partners with R&D, manufacturing, regulatory and clinical teams to influence design strategy and risk management.

You will lead design controls, V&V activities, and continuous improvement of quality processes in a fast-paced environment, ensuring compliance with ISO 13485 and ISO 14971 while

Qualifications

• 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

Quality engineering

Design assurance

Risk management

Design controls

Verification and Validation

Regulatory compliance

Written and verbal communication

Education

Bachelor of Science in Engineering

Tools

FMEA

ISO 14971 tools

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

Apply your engineering expertise to ensure patient safety and product excellence by joining the Design Assurance team within our ICVT division. As a Design Assurance Engineer II, you will support commercialized products that improve the delivery of care for patients around the world.

In this highly visible role, you will influence design strategy, risk management, and lifecycle quality activities while partnering with cross-functional leaders in R&D, manufacturing, regulatory, and clinical. You will thrive in a high-performance culture that values diversity, innovation, global collaboration and a winning spirit — where continuous learning and meaningful impact are part of every project.

This role is on-site in Penang, Malaysia, to support hands‑on collaboration and cross-functional partnership. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is available for qualified candidates.

Job 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.

Job requirements:

• 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 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.

Preferred qualifications:

• Degree in biomedical or mechanical engineering.
• Experience supporting balloon catheters, cardiovascular or implantable medical devices.
• Certification in quality engineering (e.g., CQE) or related credential.
• Demonstrated use of advanced quality tools and statistical methodologies.
• Passion for continuous improvement, talent development and building high-performing teams.