Sustaining Manufacturing Engineer

InfraredX, Inc. • Bedford, MA

92d

About The Position

The Sustaining Manufacturing Engineer will provide support to the Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met. This role involves troubleshooting current design and process challenges, determining root causes, and implementing robust solutions. The engineer will support the improvement of manufacturing procedures, inspections, and test equipment necessary to enhance manufacturing capabilities. Additionally, the engineer will implement process documentation changes and train direct labor personnel, author and execute test protocols to validate manufacturing processes and equipment, and use Lean manufacturing methods to identify improvements that reduce costs, increase yields, and ensure product quality. Collaboration with contract manufacturing sites to improve product quality and achieve company goals is also a key responsibility. The engineer will assist in maintaining systems for regulatory compliance, design, install, and troubleshoot manufacturing equipment, monitor performance of equipment, machines, and tools, and correct any issues that produce non-conforming products or low yields. Working with cross-functional groups including Product Development and Quality Engineering to analyze and disposition non-conforming products is essential, as well as implementing process and design changes to improve ergonomic issues and integrate 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)

Nice To Haves

• Knowledge of QSR and ISO 13485 requirements for Medical Devices.
• Experience with Minitab, Statgraphics, Matlab, or Python.
• Knowledge of Lean methods.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees