Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)
Skills
Analytical Skill
Collaboration
Conflict Resolution
Data Compression
Documentation
GMP
IQ
ISO 13485
Lean Manufacturing
Manufacturing
Mechanical Engineering
Medical Devices
OQ
Optimization
PQ
Problem Solving
Process Engineering
Process Improvement
Product Development
Regulatory Compliance
Six Sigma
Job Details
Title: Manufacturing Engineer Medical Devices (Compression Molding Focus)
Location: Gainesville, FL (On-site)
Duration: Long Term Contract
Position Summary:
Our client is seeking a Manufacturing Engineer with expertise in compression molding processes for the production of high-quality medical device components. The ideal candidate will drive process development, optimization, and validation activities to ensure compliance with medical industry standards.
Key Responsibilities:
- Develop and optimize compression molding processes for medical-grade materials (e.g., silicone, thermoset polymers).
- Design and qualify molds, tooling, and related equipment.
- Lead process validation activities including IQ/OQ/PQ for molding equipment and processes.
- Collaborate with Product Development teams to ensure manufacturability of new designs.
- Conduct capability studies and implement process improvements to enhance yield and reduce scrap.
- Troubleshoot molding defects and implement corrective actions.
- Ensure compliance with ISO 13485, FDA QSR, and GMP requirements.
- Maintain accurate documentation for all manufacturing processes and validations.
Qualifications:
- Bachelor s degree in Mechanical, Manufacturing, or Polymer Engineering.
- 6 -8 years of compression molding experience in a medical device manufacturing environment.
- Strong knowledge of molding materials and tooling design.
- Proven track record in process validation and regulatory compliance.
- Excellent analytical and problem-solving skills.
- Familiarity with Six Sigma or Lean Manufacturing methodologies is a plus.
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