Manufacturing Engineer /validation process engineer
Manufacturing Engineer /validation process engineer
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1 Vacancy
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.
- Bachelors or masters 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.
- Proficiency in statistical analysis tools (e.g. Minitab JMP).
- Experience with QMS systems and documentation practices.
- Excellent analytical problem-solving and communication skills.
Employment Type
Full-time
