Manufacturing Engineer

2 weeks ago

Gainesville, FL, United States Katalyst Healthcares and Life Sciences Full time
Roles & Responsibilities:
  • Protocol Review & Compliance: Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.
  • Process Audits & Documentation: Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.
  • Process Optimization: Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM. Establish and document robust process parameters and operating windows.
  • Validation Execution: Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ, OQ, PQ reports based on validation activities.
  • Statistical Analysis: Run statistical reports to analyze process capability, variability, and performance trends.
  • Change Management: Lead and document change management activities related to process improvements and equipment modifications.
  • Continuous Monitoring: Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.
  • Experience working in QMS and ERP systems.
  • Experience with IQ/OQ/PQ/TMV preferred.
  • Worked with cross functional teams.
  • Collaborate with Quality Engineering to provide manufacturing support.
  • Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
  • Should be experienced in medical device manufacturing assembly lines.
  • Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
  • Need to conduct qualification, verification, and validation activities to produce medical devices.
  • Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.
  • IQ-OQ-PQ Experience in medical parts manufacturing experience is the key, with process validation
  • Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
  • Work with CFT teams in troubleshooting problems on the production floor.
  • Bachelor's or master's degree in mechanical engineering, Biomedical Engineering, or related field.

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