- You will be responsible for reviewing and analyzing daily CM production data and planning activities to improve output and efficiency of Dexcom owned equipment performance.
- You will be asked to conduct feasibility studies and testing on new and modified designs; analyze mechanical systems, equipment, and packaging; lead the root cause analysis and investigation activities as they relate to equipment and process; and author, review and approve a variety of documentation and validation protocols.
- You will be expected to plan, design, develop and execute equipment improvement projects, including all necessary documentation under limited guidance of leadership. These projects will require communication to leadership and collaboration with cross-functional teams to ensure successful and on time completion of projects.
- You will be responsible for reviewing and approving equipment acceptance testing (FAT/SAT) and validation protocols (IQ/OQ/PQ) and reports for all new or modified production equipment at our contract manufacturing partners, and assist in protocol execution, as necessary.
- You will define and contribute to the development of product assembly equipment, system architecture, robotics concepts, and tooling with internal and external development teams.
- You will be developing test plans, equipment requirements, protocols, and reports to ensure designs meet product and part specifications, regulatory requirements, and applicable standards for new equipment and processes, including IQ/OQ/PQ protocols.
- You will participate as the Operations Mechanical/Systems Engineering representative in departmental and external project teams, providing engineering support to assembly and test personnel both in San Diego and off-site contract manufacturing partners.
- You must possess a broad understanding of technical principles and theories and be able to synthesize external data and research findings for application that may impact technical objectives.
- You must have at least 5 years of hands-on experience with high volume automation assembly machines that includes developing proof of concepts to challenge/test automation assembly methods, maintaining or developing fixtures and equipment, robotics design and development, or experience troubleshooting control systems.
- You must be able to demonstrate an understanding of Manufacturing Statistical methods, such as process capability and Design of Experiments, and be able to cite examples of how you have applied these tools to assist in development and troubleshooting of products and processes.
- You must be able to perform tolerance stack analyses and create drawing specifications using GD&T, as appropriate, and be able to able to apply engineering design and drafting tools, such as SolidWorks.
- You must be able and capable to travel to our automation vendors and contract manufacturing partners to investigate production or quality related issues and troubleshoot equipment.
- You must have excellent communication (written and verbal) and personal interaction skills. Able to organize and prioritize assignments, participate in assigned functional teams, and create and revise technical documents.
- Preference given to candidates withExperience managing projects pertaining to new equipment installation, design changes, process improvements, material cost reduction, alternate component supplier qualification, and other plant efficiency efforts. This includes a demonstrated ability to identify project requirements and develop schedules with little to no assistance from more senior level engineeringGeneral knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR and International Organization for Standardization (ISO)Experience working in a Medical device or regulated environmentSix Sigma experience
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Sr Mechanical Engineer - George Town, Malaysia - Dexcom
Description
About Dexcom
Founded in , Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year revenues of $2.9B, a growth of 18% over . Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8, people worldwide.
Summary
Under the direction of the Sr. Manager, Automation Engineering, and as part of the Global Supplier Development Engineering Team, the Senior Mechanical Engineer provides project management and technical support for moderate to complex high-speed automated equipment, primarily located at Dexcom's External Contract Manufacturing (CM) partner's clean room facilities. This individual will support sustaining engineering for equipment, process, or component-related issues and must possesses a strong technical background with the ability to conduct failure mode analyses on process equipment, as well as solid communication skills to be able to successfully implement and document corrective actions.
Job Description
Job Requirement
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Sr Mechanical Engineer professionals in George Town
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SHAWN TANG
Mechanical Engineering (Aeronautics) Undergraduate
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Christopher Tan
Graphics Designer and Videographer