Job Description

Role: Manufacturing Engineer

Location: Gainesville, FL & Sarasota, FL

Experience: 8 Years

Durations: 6+ Months

Skills: IQ-OQ-PQ Experience in medical parts manufacturing experience is the key, with process validation expertise around 8 to 10 yrs experience, and Medical Device experience is mandatory.

Job Description:

 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 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.

 Participate in 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.

Qualification:

 Bachelor’s or master’s degree in mechanical engineering, Biomedical Engineering, or related field.

 5+ years of experience in medical device manufacturing, with hands-on experience in CNC Machining and DCM.

 Strong understanding of FDA, ISO 13485, and GMP requirements.

Active Requirements

 Proficiency in statistical analysis tools (e.g., Minitab, JMP).

 Experience with QMS systems and documentation practices.

 Excellent analytical, problem-solving, and communication skills.

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