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.
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.
TheManufacturingEngineer willbe responsible forsupportingthesustaining manufacturing line to a high scale production.Youwill support processes asrequiredto provide daily operations support to the manufacturing floor including inputs tomonitoringand control tomaintainrobust processes. This role will interact with different areas in the organization including quality, R&D, Regulatory, Operations, Marketing, SupplyManagementetc.
Provide support to the manufacturingprocesses ensuringoutputSupportday-to-dayactivities as manufacturing needs to ensure optimization of manufacturingand/or investigations as needed
Responsibilities:
Oversee shift operations tomaintaincontinuous production, resolving documentation, material, and equipment issues promptly.
Act asliaisonbetween production and engineering management, providing updates and escalating issues as needed.
Author andmaintainproduction 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 toexecute calibration, process validation (IQ/OQ/PQ), and Test Method Validation (TMV) protocols.
Design andoptimizemanufacturing 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,initiatingcorrective actions tomaintainproduct quality.
Apply statistical process control techniques and provide guidance on design concepts to maximize equipment utilization and manufacturing efficiency.
BasicQualifications
Bachelor’s degree in engineering or scienceswith2+ years of experience
Strong written and verbalproficiencyin English and Malay.
Ability and willingness to travel internationally for extended periods, typically ranging from 2 to 6 months or longer,dependingon on-the-job training needs
Desired Skills & Experience:
Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
KnowledgeofGD&T & experience in interpreting mechanical drawings.
Strong communicationskills, bothverbaland written.
Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.
Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485 is preferred.
KnowledgeofEngineering Change management processes and PLM tools such asAgile,PTC Windchill is preferred. (Any PLM)
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.
