Manufacturing Engineer II

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Together, we can change healthcare worldwide which is why we’re embarking on a new venture in Malaysia and want you to be a part the next generation of life-changing medical technology to patients worldwide by being a part of our next chapter of innovation in Malaysia. Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting commitment to our new venture in Malaysia. The   Manufacturing   Engineer will   be responsible for   supporting   the   sustaining manufacturing line to a high scale production.   You   will support processes as   required   to provide daily operations support to the manufacturing floor including inputs to   monitoring   and control to   maintain   robust processes. This role will interact with different areas in the organization including quality, R&D, Regulatory, Operations, Marketing, Supply   Management   etc.    Provide support to the manufacturing   processes ensuring   output .   Support   day-to-day   activities as manufacturing needs to ensure optimization of manufacturing   and/or investigations as needed .

Oversee shift operations to   maintain   continuous production, resolving documentation, material, and equipment issues promptly.    Act as   liaison   between production and engineering management, providing updates and escalating issues as needed.    Author and   maintain   production documents, templates, reports, specifications, and equipment protocols; conduct equipment qualifications and validations.    Investigate and resolve equipment, process, and product non-conformances through root cause analysis and corrective actions.    Develop innovative solutions to recurring production challenges and collaborate with production personnel on improvement initiatives.    Provide training and support to production teams to enhance process understanding and efficiency.    Partner with New Product Introduction/Transfer teams to   execute calibration, process validation (IQ/OQ/PQ), and Test Method Validation (TMV) protocols.    Design and   optimize   manufacturing processes, layouts, and workflows for assemblies, equipment installation, and material handling.    Ensure compliance with regulatory requirements and incorporate inspection and test requirements into production plans.    Monitor and improve machinery performance,   initiating   corrective actions to   maintain   product quality.    Apply statistical process control techniques and provide guidance on design concepts to maximize equipment utilization and manufacturing efficiency.   Basic   Qualifications :   Bachelor’s degree in engineering or sciences   with   2 + years of experience    Strong written and verbal   proficiency   in English and Malay.   Ability and willingness to travel internationally for extended periods, typically ranging from 2 to 6 months or longer,   depending   on on-the-job training needs .     Desired Skills & Experience:   Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.   Knowledge   of   GD&T & experience in interpreting mechanical drawings.   Strong communication   skills, both   verbal   and written.   Experience with risk