Manufacturing Engineer II

Job description

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 LifeTogether, 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. Responsibilities: 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 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. Knowledge of Engineering Change management processes and PLM tools such as Agile, 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. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com 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 AskHR@medtronic.com. ‌ Benefits & CompensationMedtronic 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).