Hello,
Kindly go through the below job description and let me know if you are interested in this position.
Role: Manufacturing Engineer – Medical Devices (Compression Molding Focus)
Location: Gainesville, FL
Summary
Seeking an experienced Manufacturing Engineer specializing in compression molding for medical device components. Responsible for process development, optimization, validation, and ensuring compliance with ISO 13485, FDA QSR, and GMP standards.
Key Responsibilities
- Develop and optimize compression molding processes for medical-grade materials.
- Design and qualify molds, tooling, and equipment.
- Lead IQ/OQ/PQ validation activities.
- Collaborate with product development for manufacturability.
- Conduct capability studies and implement process improvements.
- Troubleshoot defects and apply corrective actions.
Qualifications
- Bachelor’s in Mechanical, Manufacturing, or Polymer Engineering.
- 6+ years compression molding experience in medical devices.
- Knowledge of molding materials and tooling design.
- Experience in process validation and regulatory compliance.
- Familiarity with Six Sigma/Lean is a plus.