Job Description

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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