Manufacturing Engineer II
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Job Summary
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 95000 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 career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain restore health and extend lifea commitment that provides life-transforming technologies that treat more than 70 health conditions across cardiovascular neuroscience and surgical 2025 our products and therapies treated more than 75M people thats two people every second of every hour of every day.
Together we can change healthcare worldwide which is why were 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 worlds 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 asto 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 ensuringoutput.Supportday-to-dayactivities as manufacturing needs to ensure optimization of manufacturingand/or investigations as needed.
Primary 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 performanceinitiatingcorrective actions tomaintainproduct quality.
Apply statistical process control techniques and provide guidance on design concepts to maximize equipment utilization and manufacturing efficiency.
BasicQualifications:
Bachelors 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 longerdependingon on-the-job training needs.
Required Qualifications:
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 asAgilePTC 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.
Recruitment Fraud Alert
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
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 .
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.
Required Experience:
IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
