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Senior Manufacturing Engineer

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NTT DATA

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Location:
United States , Florida

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

We are seeking an experienced Senior Manufacturing Engineer to lead complex process improvement initiatives, provide technical mentorship, and drive quality and operational excellence within a regulated medical device manufacturing environment. This role partners cross-functionally with R&D, Quality, and Operations to transition products from concept to full-scale production while ensuring high-quality, compliant, and cost-effective manufacturing processes.

Job Responsibility:

  • Develop, implement, and optimize manufacturing processes including molding, laser welding, and bonding to improve efficiency, yield, and cost performance
  • Apply Lean Six Sigma methodologies and Design of Experiments (DOE) to drive continuous improvement
  • Create, update, and maintain manufacturing documentation including PFMEAs, Control Plans, SOPs, and Work Instructions in compliance with FDA and ISO 13485 requirements
  • Ensure processes are robust, scalable, and aligned with regulatory and quality standards
  • Lead cross-functional teams on process improvement, cost reduction, and capital equipment acquisition projects
  • Oversee equipment selection, installation, and validation activities (IQ/OQ/PQ)
  • Collaborate with suppliers to establish process capability and ensure material and component quality
  • Drive operational excellence initiatives to enhance productivity and reduce manufacturing risk
  • Provide technical leadership and mentorship to junior engineers, technicians, and production staff
  • Support R&D through Design for Manufacturability (DFM) reviews and early-stage process development
  • Develop and deliver training on new equipment, tools, and manufacturing procedures
  • Foster a culture of accountability, innovation, and continuous learning
  • Lead root cause analysis (RCA) investigations for production and quality issues using structured problem-solving tools
  • Drive CAPA initiatives and ensure timely, effective resolution of non-conformances
  • Maintain strict adherence to FDA regulations, ISO 13485 standards, and internal quality systems
  • Support internal and external audits as required

Requirements:

  • Bachelor's degree in Mechanical, Manufacturing, Biomedical, or related Engineering discipline
  • Minimum of 10+ years of experience in medical device manufacturing
  • Demonstrated experience in regulated environments (FDA, ISO 13485)
  • 5+ years of proficiency in CAD software (Creo and/or SolidWorks)
  • Strong statistical analysis skills with Minitab or similar tools
  • Working knowledge of Lean Six Sigma principles (certification preferred)
  • 3 to 5 years of experience with process validation (IQ/OQ/PQ) and DOE methodologies
  • 3 to 5 years of hands-on experience with molding, laser welding, bonding, or similar precision manufacturing processes

Nice to have:

Advanced degree preferred

Additional Information:

Job Posted:
April 23, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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