Amirul Hakim Ishak
About Amirul Hakim Ishak
Amirul Hakim Ishak is a Senior Material Engineer at Teleflex Incorporated with extensive experience in materials engineering and medical device compliance.
Current Position at Teleflex Incorporated
Amirul Hakim Ishak is currently employed as a Senior Material Engineer at Teleflex Incorporated. In this role, he is responsible for conducting process validation, including installation qualification, operational qualification, and performance qualification, adhering to Global Harmonization Task Force guidelines. He also establishes biocompatibility testing strategies compliant with ISO 10993-1:2018 and applies the ISO 13485:2016 standards for managing medical device quality systems. Additionally, he engages in risk management activities in line with ISO 14971:2019 and ensures compliance with Medical Device Regulation (MDR).
Previous Experience at KISWIRE SDN. BHD.
From 2013 to 2017, Amirul Hakim Ishak held the position of Senior Material Engineer at KISWIRE SDN. BHD. in Johor Bahru, Johore, Malaysia. During his tenure, he led a team of engineers to resolve production line issues, conducted failure analysis to identify root causes of product defects, and tested, evaluated, and approved consumables for production line implementation. Additionally, he designed and fabricated lab test machines to meet market demands and conducted pilot scale production for new products before their full-scale implementation. He regularly presented project progress to the board of directors and collaborated with local universities for testing and joint research activities.
Educational Background in Materials Engineering
Amirul Hakim Ishak obtained his Bachelor's degree in Materials Engineering from McMaster University, where he studied from 2009 to 2013. Prior to that, he completed a High School Diploma in Engineering at Taylor's University between 2008 and 2009. These educational achievements laid a solid foundation for his career in material engineering and equipped him with the necessary knowledge and skills essential for his professional roles.
Key Achievements and Certifications
Amirul Hakim Ishak has been recognized for his professional excellence and contributions. He received the Kiswire 2016 Best Achievement Award and was a finalist in the Connection competition at the 2013 OCE Discovery Conference. Amirul was awarded McMaster University Entrance Awards in 2009. Additionally, he is a Certified Quality Professional by the Association of Malaysian Medical Industries, obtained in 2018. These accolades underscore his commitment to engineering excellence and industry standards.
Skills and Proficiencies
Amirul Hakim Ishak is proficient in both English and Malay, with strong capabilities in written and oral communication. He possesses robust management and leadership skills, excelling in problem-solving and analytical analysis. His technical skills include the use of Microsoft Office and handling various types of lab testing machines. Amirul also has a strong background in economics, which complements his engineering expertise and enhances his ability to manage projects and teams effectively.