Infraredx, a Nipro Company
Sustaining Manufacturing Engineer
Infraredx, a Nipro Company, Bedford, Massachusetts, us, 01730
Job Title
Sustaining Manufacturing Engineer Company
InfraReDx Responsibilities
Provides support to the Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met. Troubleshoot current design and process challenges, determine root cause, and implement robust solutions. Support the improvement of manufacturing procedures, inspections and test equipment necessary to improve the capabilities manufacturing. Implement process documentation changes and train direct labor personnel. Author and execute test protocols to validate manufacturing processes and equipment. Use Lean manufacturing methods and identify improvements to reduce costs, increase yields, and ensure product quality. Collaborate with contract manufacturing sites to improve product quality and achieve company goals. Assist in maintaining systems for regulatory compliance. Design, install and troubleshoot manufacturing equipment. Monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Work with cross-functional groups including Product Development and 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. Requirements
Strong communication and interpersonal skills. Bachelor of Science Degree in mechanical, electrical, or manufacturing engineering. Minimum of 1-3 years’ experience in medical device manufacturing Experience supporting manufacturing process development, validations and qualifications Proficient understanding of analog/digital electronics. Proficiency with a variety of test equipment to include digital meters and power supplies. Proficiency with Microsoft Office applications and Solidworks Ability to interact with client companies (customer focused) and co-workers in a professional manner. 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) Preferred
Knowledge of QSR and ISO 13485 requirements for Medical Devices. Experience with Minitab, Statgraphics, Matlab, or Python Knowledge of Lean methods Seniority level
Entry level Employment type
Full-time Job function
Manufacturing and Engineering Industries
Medical Equipment Manufacturing
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Sustaining Manufacturing Engineer Company
InfraReDx Responsibilities
Provides support to the Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met. Troubleshoot current design and process challenges, determine root cause, and implement robust solutions. Support the improvement of manufacturing procedures, inspections and test equipment necessary to improve the capabilities manufacturing. Implement process documentation changes and train direct labor personnel. Author and execute test protocols to validate manufacturing processes and equipment. Use Lean manufacturing methods and identify improvements to reduce costs, increase yields, and ensure product quality. Collaborate with contract manufacturing sites to improve product quality and achieve company goals. Assist in maintaining systems for regulatory compliance. Design, install and troubleshoot manufacturing equipment. Monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Work with cross-functional groups including Product Development and 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. Requirements
Strong communication and interpersonal skills. Bachelor of Science Degree in mechanical, electrical, or manufacturing engineering. Minimum of 1-3 years’ experience in medical device manufacturing Experience supporting manufacturing process development, validations and qualifications Proficient understanding of analog/digital electronics. Proficiency with a variety of test equipment to include digital meters and power supplies. Proficiency with Microsoft Office applications and Solidworks Ability to interact with client companies (customer focused) and co-workers in a professional manner. 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) Preferred
Knowledge of QSR and ISO 13485 requirements for Medical Devices. Experience with Minitab, Statgraphics, Matlab, or Python Knowledge of Lean methods Seniority level
Entry level Employment type
Full-time Job function
Manufacturing and Engineering Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr