Manufacturing Engineer

Intellectt Inc; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device manufacturer in Minneapolis is seeking a Manufacturing / Validation Engineer. This role involves collaborating with equipment suppliers, validating laser welding processes, and developing manufacturing methods. Candidates should possess a BS in Packaging Science or Mechanical Engineering and at least 5 years of experience in the medical device sector. The position offers a chance to impact quality and efficiency within a dynamic team environment.

Qualifications

• BS in Packaging Science, Mechanical Engineering, or equivalent; MS in Engineering preferred.
• Minimum 5 years’ experience in the medical device industry.

Responsibilities

• Collaborate with equipment suppliers and machine builders during design.
• Work with semi-automated/automated equipment; Laser Welding validation mandatory.
• Conduct qualification and validation for medical devices.

Skills

Collaboration with suppliers

Troubleshooting manufacturing issues

Process development across manufacturing methods

Education

BS in Packaging Science or Mechanical Engineering

MS in Engineering

Job description

• Collaborate with equipment suppliers and machine builders during design and kick-off.
• Work with semi-automated/automated equipment; Laser Welding machine validation mandatory.
• Develop processes across multiple manufacturing methods.
• Review prints and update designs as needed.
• Operate within QMS and ERP systems.
• Perform IQ/DOE/OQ/PQ/TMV activities (preferred).
• Collaborate with cross-functional teams and Quality Engineering.
• Provide manufacturing support, including change and risk analysis, and ensure readiness.
• Troubleshoot issues affecting safety, quality, cost, or delivery.
• Conduct qualification, verification, and validation for medical devices.

Qualifications:

• BS in Packaging Science, Mechanical Engineering, or equivalent; MS in Engineering preferred.
• Minimum 5 years’ experience in the medical device industry.
• Title: Manufacturing / Validation Engineer.