Design Quality Assurance Engineer II

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 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.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.