Senior Manufacturing Engineer – Medical Devices

Advantage Technical; Fort Snelling Unorganized Territory (MN); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Disability insurance

Job summary

A leading staffing firm is seeking a Senior Manufacturing Engineer to lead design transfer and optimize processes for catheter-based medical devices. This 6-month contract role requires a BS in Mechanical Engineering and at least 5 years of experience in manufacturing and quality systems. Ideal candidates possess strong skills in lean manufacturing and project management, along with catheter experience.

Qualifications

• 5+ years of experience in manufacturing engineering.
• Strong understanding of compliance: ISO 13485 and QMS.
• Catheter experience is strongly preferred.

Responsibilities

• Lead design transfer and process optimization for medical devices.
• Support launch and updates of drug-device products.
• Implement lean manufacturing improvements to reduce timelines.

Skills

Lean manufacturing

Project management

Quality systems

DFM knowledge

Six Sigma (Green Belt+)

Education

BS in Mechanical Engineering or related

Job description

Senior Manufacturing Engineer – Medical Devices

Senior Manufacturing Engineer – Medical Devices

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Our client is hiring a Senior Manufacturing Engineer to lead design transfer and process optimization for catheter-based medical devices.

This is a 6 month contract role.

Responsibilities:

• Support launch and updates of drug-device products.
• Optimize coating processes, equipment, and production layout.
• Drive DFM, PFMEA, DFMEA, and CTQ activities.
• Lead validation: IQ, OQ, PQ, MSA.
• Implement lean improvements and reduce transfer timelines.
• Create documentation: Work Instructions, Control Plans, Safety Analysis.
• Ensure compliance with ISO 13485 and QMS standards.

Requirements:

• BS in Mechanical Engineering (or related).
• 5+ years of experience.
• Strong in lean manufacturing, quality systems, and project management.
• Knowledge of DFM, Six Sigma (Green Belt+), Lean Six Sigma, ERP systems.
• Catheter experience strongly preferred.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing and Other

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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