Manufacturing Engineer II

Insight Global; Saint Paul (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Insight Global in Minnesota is seeking a Manufacturing Engineer II to own one or more product lines at a medical device contract manufacturer. You’ll be the main technical contact, resolve production issues, and implement customer-requested changes while focusing on sustaining production.

Work with Production, Quality, and NPI Engineering to meet build plans, drive continuous improvement, maintain BOMs and procedures, and ensure regulatory compliance.

Qualifications

• Bachelor's degree in an engineering discipline.
• 3+ years of manufacturing engineering experience (not entry-level).
• At least half of that time in sustaining manufacturing (owning products in production, fixing repeat issues, improving quality).
• Lean Six Sigma Yellow or Green Belt training.
• Experience creating and maintaining production documents: BOMs, procedures, drawings, ECOs.
• Comfortable being the technical contact for customers, including process changes and obsolescence.
• Strong communication and teamwork with Production, Quality, NPI, and customers.
• SolidWorks experience.
• Independent worker able to manage several product lines at once.
• Medical device manufacturing experience (aerospace also accepted).
• Complex electro-mechanical or electronics-based manufacturing experience.
• Experience in regulated environments (FDA QSR, ISO 13485, ISO 9001).
• Experience moving new products from NPI into sustaining production.

Responsibilities

• Own the production builds for one or more product lines, including issues, improvements and changes.
• Be the technical lead on customer calls; recommend replacements for obsolete parts and scope changes.
• Act on floor feedback to fix problems and improve equipment and processes.
• Track production issues, find root causes and put lasting fixes in place.
• Lead continuous improvement to reduce scrap, improve yield, and lower costs.
• Create and maintain production documents: BOMs, procedures, drawings and ECOs.
• Work with Quality on documents and concerns for your lines.
• Move new products from NPI into sustaining production.
• Keep the production team updated on status and build plans.
• Stay current on medical device requirements and manufacturing processes.

Skills

Manufacturing engineering experience

Sustaining manufacturing

Lean Six Sigma Yellow/Green Belt

Strong communication

Documentation and records

Regulatory compliance knowledge

Education

Bachelor's degree in engineering

Tools

SolidWorks

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 certificationExperience 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 [e-mail].