Manufacturing Engineer â Medical Devices (Compression Molding Focus)
Manufacturing Engineer â Medical Devices (Compression Molding Focus)
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1 Vacancy
Job Description
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:
- Bachelors 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.
Employment Type
Full-time
