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
  
  Not Applicable

• Employment type
  
  Full-time

• Job function
  
  Manufacturing and Other
• Industries Medical Equipment Manufacturing

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Medical insurance

Vision insurance

401(k)

Disability insurance

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