Manufacturing Engineer

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.
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.
•            Proficiency in statistical analysis tools (e.g., Minitab, JMP).
•            Experience with QMS systems and documentation practices.
•            Excellent analytical, problem-solving, and communication skills