Sustaining Manufacturing Engineer II – Medical Devices

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 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.