NextGen IT Labs
Overview
Manufacturing Engineer – Warsaw, IN (Onsite). Contract role (W2). OPT will work Responsibilities
Experience supporting medical device manufacturing process validations, including process characterization, equipment IQ/OQ, process OQ, and PQ. Experience with Test Method Validation and Gage R&R. Root cause analysis and problem solving for technical and process issues. Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485:2003. Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner. Apply quality and statistical tools for problem solving. BOM and Router creation and updates. Ability to read and understand engineering drawings. Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), and Critical-to-Quality (CTQ) Analysis. Knowledge of Quality System requirements, ISO and FDA requirements. Effectively work within a cross-functional team to complete critical project tasks. Demonstrates good written and verbal communication skills. Experience with control procedures, such as Change Management System, Nonconformance Reports, Engineering Specifications, CAPA, and Work Instructions; proficient with Statistical Process Control concepts; Microsoft Office Suite and Project. 4-6 years of relevant experience. Develops and executes process validation strategies: creates plans, protocols (IQ/OQ/PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures regulatory compliance: adheres to FDA 21 CFR 820, ISO 13485, and other relevant regulations, participates in audits, and maintains up-to-date knowledge. Analyzes data and reports findings: compiles and analyzes validation data, writes comprehensive reports, identifies trends for process improvement. Collaborates cross-functionally with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support. Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training. Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers. Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc. Conducting feasibility studies to estimate product cost. Qualifications
4-6 years of experience in manufacturing engineering or related field. On-site work in Warsaw, IN.
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Manufacturing Engineer – Warsaw, IN (Onsite). Contract role (W2). OPT will work Responsibilities
Experience supporting medical device manufacturing process validations, including process characterization, equipment IQ/OQ, process OQ, and PQ. Experience with Test Method Validation and Gage R&R. Root cause analysis and problem solving for technical and process issues. Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485:2003. Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner. Apply quality and statistical tools for problem solving. BOM and Router creation and updates. Ability to read and understand engineering drawings. Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), and Critical-to-Quality (CTQ) Analysis. Knowledge of Quality System requirements, ISO and FDA requirements. Effectively work within a cross-functional team to complete critical project tasks. Demonstrates good written and verbal communication skills. Experience with control procedures, such as Change Management System, Nonconformance Reports, Engineering Specifications, CAPA, and Work Instructions; proficient with Statistical Process Control concepts; Microsoft Office Suite and Project. 4-6 years of relevant experience. Develops and executes process validation strategies: creates plans, protocols (IQ/OQ/PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures regulatory compliance: adheres to FDA 21 CFR 820, ISO 13485, and other relevant regulations, participates in audits, and maintains up-to-date knowledge. Analyzes data and reports findings: compiles and analyzes validation data, writes comprehensive reports, identifies trends for process improvement. Collaborates cross-functionally with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support. Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training. Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers. Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc. Conducting feasibility studies to estimate product cost. Qualifications
4-6 years of experience in manufacturing engineering or related field. On-site work in Warsaw, IN.
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