Senior Sustaining Manufacturing Engineer
Responsibilities:
Sustain Support the organization to facilitate efficient operations within the production area, optimize existing processes, and ensure production goals are met.
Troubleshoot design and process challenges, determine root cause and implement robust solutions.
Assist in maintaining systems for ISO 13485 certification.
Monitor performance of equipment, machines and tools.
Corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
Work with cross-functional groups to analyze and disposition non-conforming products.
Support acute and long-term projects of contract manufacturing facility remotely and in-person Continuously Improve Implement documentation changes and train direct labor personnel.
Improve procedures, inspections and test equipment necessary to improve the capabilities manufacturing.
Employ Lean and Six Sigma manufacturing methods to reduce waste.
Identify opportunities for product and process improvements that reduce costs and increase yields by creating tooling, production equipment, assembly methods, quality control standards, product design, materials and parts.
Implement process and design changes to improve ergonomic issues as well as integrating products into Lean Manufacturing.
Develop and Validate Create and execute test protocols to validate manufacturing processes and test methods.
Assist with the design, installation and troubleshooting manufacturing equipment.
Assist in designing, develop, and validation of tools and fixtures.
Interface with suppliers to define requirements and improve overall product quality.
Requirements:
Bachelor of Science in mechanical or manufacturing engineering Knowledge of QSR and ISO 13485 requirements for Medical Devices.
Minimum of 5
years experience in medical device manufacturing Experience in manufacturing process development, validations and qualifications Experience with manufacturing process improvements.
Proficient understanding of analog/digital electronics.
Proficiency with a variety of test equipment to include oscilloscopes, digital meters, power supplies.
Hands on experience implementing a Lean Manufacturing environment.
Proficiency with Microsoft Office applications, knowledge of Solidworks Ability to execute projects with minimal supervision.
Strong communication and interpersonal skills.
Travel to vendors and customer sites as needed (?20% travel).
Ability to interact with client companies (customer focused) and co-workers in a professional manner.
Self-motivation, focus, determination, self-reliance, open-mindedness, amiability, and flexibility.
Preferred:
Masters of Science in mechanical or manufacturing engineering Knowledge of Six Sigma methods Adhesive bonding development experience Proficiency with Labview & Matlab Design for Manufacture and Design for Assembly experience PI225571094 Recommended Skills Communication Iso 13485 Industrial Production Interpersonal Skills Lab View Lean Manufacturing Estimated Salary: $20 to $28 per hour based on qualifications.
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