Job Description Insight Global is looking for a Manufacturing Engineer II to own one or more product lines at a medical device contract manufacturer. The role is on the sustaining side of the business. You'll be the main technical contact for your product lines, both inside the company and with customers. You'll resolve production issues, make process and equipment improvements, and put customer-requested changes in place. Customers decide how their products are built, so you'll focus on improving and changing the manufacturing process rather than redesigning products. You'll work closely with Production, Quality, NPI Engineering and customers to hit build plans safely and to a high quality standard.

Key Responsibilities:

• Own the production builds for one or more product lines, including the issues list, improvements and changes
• Be the technical lead on customer calls: recommend replacements for obsolete parts and scope and carry out customer-requested process changes
• Act on feedback from the production floor to fix problems and improve equipment and processes
• Track production issues, find root causes and put lasting fixes in place
• Lead continuous improvement work: less scrap, better yield, better labor efficiency and lower costs
• Create and maintain production documents, including bills of materials, procedures, drawings and change orders
• Work with Quality on quality documents, issues and concerns for your product lines
• Work with NPI Engineering to move new products into sustaining production
• Keep the production team updated on status and help meet build plans
• Stay current on medical device requirements and on new and existing manufacturing processes Skills and Requirements
• Bachelor's degree in an engineering discipline
• 3+ years of manufacturing engineering experience (this is not an entry-level role)
• At least half of that time in sustaining manufacturing. That means owning products already in production: fixing repeat issues, understanding how they fail, cutting costs and improving quality.
• Lean Six Sigma training or hands-on use (Yellow or Green Belt preferred; Black Belt not required)
• Experience creating and maintaining production documents: bills of materials, assembly and test procedures, part drawings and engineering change orders
• Comfortable being the technical contact for customers, including calls about process changes and parts that are going obsolete
• Strong communication and teamwork skills, working with Production, Quality, NPI Engineering and customers
• SolidWorks experience
• Can work independently and manage several product lines at once
• Medical device manufacturing experience (aerospace also accepted)
• Complex electro-mechanical or electronics-based manufacturing experience, beyond lower-complexity disposables like catheters
• Experience in regulated environments (FDA

QSR, ISO 13485, ISO 9001

)

• Formal Lean Six Sigma Yellow or Green Belt certification
• Experience moving new products from NPI into sustaining production We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.