Our client, an established contract manufacturer in the medical device industry, is seeking a Manufacturing Engineer to join their growing team.

Located in St. Paul, MN

Direct Hire
Pay: $75k-115k
Onsite position
Key Responsibilities:

• Troubleshoot manufacturing issues using Lean Six Sigma, DMAIC, and root cause analysis tools (e.g., ICARS, SCARS, CARS)

• Improve existing manufacturing processes to enhance quality, efficiency, and cost-effectiveness

• Lead technical transfers from development to production, including equipment, tooling, and process validations

• Write and execute IQ/OQ/PQ protocols and assist in report generation

• Assess and qualify material changes

• Support continuous improvement and Lean Six Sigma initiatives

• Identify and implement cost-saving projects that positively impact operational performance

• Ensure adherence to GDP, GMP, 21 CFR Part 820, and ISO 13485 compliance standards

Qualifications:

• Bachelor's degree in Mechanical Engineering (BSME) or a related field from an accredited university

• Minimum 3 years of experience in a regulated manufacturing environment (preferably medical devices)

• Experience with rotary equipment, project management, root cause analysis, non-conformance handling

• Familiarity with OGP programming, GD&T, and technical drawing interpretation

This description reflects an ideal candidate profile. If you meet some but not all of the requirements, we still encourage you to apply. We'd love to learn more about your background and potential fit for the role.

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