Design Quality Assurance Engineer

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 60,000 - 90,000; Full time

Job summary

Boston Scientific is seeking a Design Assurance Engineer II in Penang, Malaysia, to join our ICVT division and help ensure patient safety and product excellence for globally delivered medical devices. This on‑site role emphasizes collaboration with cross‑functional teams across R&D, manufacturing, regulatory and clinical to support lifecycle quality and risk management.

You will influence design strategy, risk management, and lifecycle quality activities while partnering with cross‑functional

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.

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

Risk management

Design controls

Verification & validation

Regulatory standards awareness

Education

Bachelor of Science in Engineering

Job description

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.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.