Manufacturing Engineer - Catheter InfraReDx
THIS JOB HAS EXPIRED Responsibilities:
Provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met.
Troubleshoot current design and processes, determine root cause and implement robust solutions.
Interface with manufacturing suppliers to define requirements and improve component quality.
Improve manufacturing procedures, inspections and test equipment necessary to improve the capabilities manufacturing.
Implement process documentation changes and train direct labor personnel.
Assist with creating and executing test protocols to validate manufacturing processes and equipment.
Optimize process flow and reliability using Lean and Six Sigma Manufacturing methods.
Manage maintenance program, check proper function of manufacturing equipment and ensure workplace safety.
Assist in maintaining systems for ISO 13485 certification.
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.
Assist with the design, installation and troubleshooting manufacturing equipment.
Assist in designing, develop, and validation of tooling and fixturing.
Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
Support daily production activities by troubleshooting process and equipment issues.
Work with cross-functional groups including Quality Engineering to analyze and disposition non-conforming products.
Implement process and design changes to improve ergonomic issues as well as integrating products into Lean Manufacturing.
Bachelor of Science in mechanical, or manufacturing engineering.
Knowledge of QSR and ISO 13485 requirements for Medical Devices.
Minimum of 2 years industrial experience in medical device manufacturing.
Experience with manufacturing process improvements.
Design for manufacture and assembly experience is preferred.
Ability to interact with client companies (customer focused) and co-workers in a professional manner.
Hands on experience implementing a Lean Manufacturing environment.
Knowledge of Six Sigma methods a plus.
Proficiency with Microsoft Office applications, knowledge of Solidworks, (Labview, Matlab a plus).
Strong communication and interpersonal skills.
Ability to execute projects with minimal supervision.
Willingness to support other functions as needed, in areas such as quality and design.
Willingness to travel to vendors and customer sites as needed (10% travel).
Experience in manufacturing process development, validations and qualifications
Self-motivation, focus, determination, self-reliance, open-mindedness, amiability, and flexibility.
||34 Third Avenue |
Burlington, MA 01803
THIS JOB HAS EXPIRED