Senior Medical Device Manufacturing Process Leader

BD

Sumter (SC)

On-site

USD 90,000 - 150,000

Full time

4 days ago
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Job summary

BD is seeking a Senior Manufacturing Process Engineer to lead process improvements, automation projects, and capital initiatives in a regulated medical device environment. You will drive OEE improvements, waste reduction, and product quality while ensuring FDA QSR and ISO 13485 compliance.

Collaboration across Operations, Quality, Maintenance, and R&D is essential. The role emphasizes technical leadership, project management, and hands-on optimization of high-speed automated assembly systems and

Qualifications

  • Bachelor’s degree in Mechanical, Manufacturing or Industrial Engineering.
  • Minimum of 3 years of manufacturing engineering experience in a regulated environment.
  • Experience supporting high-speed automated manufacturing and assembly equipment.
  • Strong multi-project management and mechanical troubleshooting skills.

Responsibilities

  • Lead Lean Manufacturing and Continuous Improvement initiatives to reduce waste and improve quality.
  • Analyze production data to identify OEE losses, scrap, downtime, and defects.
  • Drive Cost-to-Win programs to improve efficiency and costs.
  • Design, troubleshoot, validate, and optimize automated equipment for medical devices.
  • Lead capital equipment projects from concept to production release.

Skills

Mechanical troubleshooting
Problem-solving
Project management
Waste reduction

Education

Bachelor’s Degree in Mechanical, Manufacturing or Industrial Engineering

Tools

IQ/OQ/PQ validation
CAPA systems
Automation equipment design

Job description

BD is seeking a Senior Manufacturing Process Engineer to lead process improvements, automation projects, and capital initiatives in a regulated medical device environment. You will drive OEE improvements, waste reduction, and product quality while ensuring FDA QSR and ISO 13485 compliance.

Collaboration across Operations, Quality, Maintenance, and R&D is essential. The role emphasizes technical leadership, project management, and hands-on optimization of high-speed automated assembly systems and

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