Location: Gainesville, FL (Onsite)
Type: Contract
Position Summary: We are 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+ 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.