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Sustaining Manufacturing Engineer (Bedford)

Sustaining Manufacturing Engineer (Bedford)

Infraredx, a Nipro CompanyBedford, MA, US
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Sustaining Manufacturing Engineer

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
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    Sustaining Engineer • Bedford, MA, US

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