Design Lead

Job description

Nagaraj Replacement NPI (New Product Introduction) Engineer with strong expertise in Verification & Validation (V&V) and equipment/process qualification activities including IQ, OQ, and PQ . The candidate will play a key role in introducing new products and manufacturing processes while ensuring compliance with quality, regulatory, and validation requirements.Key ResponsibilitiesLead New Product Introduction (NPI) activities from development through production launch.Plan and execute Verification & Validation (V&V) activities for manufacturing processes, equipment, and systems.Develop, review, and execute validation protocols including:Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Prepare validation documentation, test plans, reports, risk assessments, and traceability matrices.Collaborate with cross-functional teams including Manufacturing, Quality, R&D, Process Engineering, and Supply Chain.Support process characterization, process capability studies, and equipment qualification.Analyze validation and test results, identify failures, perform root cause analysis, and implement corrective actions.Ensure compliance with GMP, FDA, ISO 13485, and other applicable regulatory standards.Support engineering change orders (ECO), process improvements, and continuous improvement initiatives.Participate in design reviews, risk management (FMEA), and product transfer activities.Required QualificationsBachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related field.6+ years of experience in NPI, Manufacturing Engineering, Validation Engineering, or Quality Engineering.Hands-on experience with:Verification & Validation (V&V)IQ/OQ/PQ Protocol Development and ExecutionEquipment QualificationProcess ValidationRisk Assessments (FMEA)Root Cause AnalysisExperience in regulated manufacturing environments such as Medical Devices, Life Sciences, Pharmaceutical, or High-Tech Manufacturing.Strong knowledge of validation lifecycle and documentation requirements.Excellent problem-solving, communication, and project coordination skills.Preferred QualificationsExperience with Medical Device manufacturing and FDA regulations.Knowledge of ISO 13485, GMP, GAMP 5, and CFR Part 820.Experience with statistical analysis tools (Minitab or equivalent).Exposure to automation systems, MES, or manufacturing process controls. Key Responsibilities Nagaraj Replacement NPI (New Product Introduction) Engineer with strong expertise in Verification & Validation (V&V) and equipment/process qualification activities including IQ, OQ, and PQ . The candidate will play a key role in introducing new products and manufacturing processes while ensuring compliance with quality, regulatory, and validation requirements.Key ResponsibilitiesLead New Product Introduction (NPI) activities from development through production launch.Plan and execute Verification & Validation (V&V) activities for manufacturing processes, equipment, and systems.Develop, review, and execute validation protocols including:Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Prepare validation documentation, test plans, reports, risk assessments, and traceability matrices.Collaborate with cross-functional teams including Manufacturing, Quality, R&D, Process Engineering, and Supply Chain.Support process characterization, process capability studies, and equipment qualification.Analyze validation and test results, identify failures, perform root cause analysis, and implement corrective actions.Ensure compliance with GMP, FDA, ISO 13485, and other applicable regulatory standards.Support engineering change orders (ECO), process improvements, and continuous improvement initiatives.Participate in design reviews, risk management (FMEA), and product transfer activities.Required QualificationsBachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related field.6+ years of experience in NPI, Manufacturing Engineering, Validation Engineering, or Quality Engineering.Hands-on experience with:Verification & Validation (V&V)IQ/OQ/PQ Protocol Development and ExecutionEquipment QualificationProcess ValidationRisk Assessments (FMEA)Root Cause AnalysisExperience in regulated manufacturing environments such as Medical Devices, Life Sciences, Pharmaceutical, or High-Tech Manufacturing.Strong knowledge of validation lifecycle and documentation requirements.Excellent problem-solving, communication, and project coordination skills.Preferred QualificationsExperience with Medical Device manufacturing and FDA regulations.Knowledge of ISO 13485, GMP, GAMP 5, and CFR Part 820.Experience with statistical analysis tools (Minitab or equivalent).Exposure to automation systems, MES, or manufacturing process controls. Skill Requirements Nagaraj Replacement NPI (New Product Introduction) Engineer with strong expertise in Verification & Validation (V&V) and equipment/process qualification activities including IQ, OQ, and PQ . The candidate will play a key role in introducing new products and manufacturing processes while ensuring compliance with quality, regulatory, and validation requirements.Key ResponsibilitiesLead New Product Introduction (NPI) activities from development through production launch.Plan and execute Verification & Validation (V&V) activities for manufacturing processes, equipment, and systems.Develop, review, and execute validation protocols including:Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Prepare validation documentation, test plans, reports, risk assessments, and traceability matrices.Collaborate with cross-functional teams including Manufacturing, Quality, R&D, Process Engineering, and Supply Chain.Support process characterization, process capability studies, and equipment qualification.Analyze validation and test results, identify failures, perform root cause analysis, and implement corrective actions.Ensure compliance with GMP, FDA, ISO 13485, and other applicable regulatory standards.Support engineering change orders (ECO), process improvements, and continuous improvement initiatives.Participate in design reviews, risk management (FMEA), and product transfer activities.Required QualificationsBachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related field.6+ years of experience in NPI, Manufacturing Engineering, Validation Engineering, or Quality Engineering.Hands-on experience with:Verification & Validation (V&V)IQ/OQ/PQ Protocol Development and ExecutionEquipment QualificationProcess ValidationRisk Assessments (FMEA)Root Cause AnalysisExperience in regulated manufacturing environments such as Medical Devices, Life Sciences, Pharmaceutical, or High-Tech Manufacturing.Strong knowledge of validation lifecycle and documentation requirements.Excellent problem-solving, communication, and project coordination skills.Preferred QualificationsExperience with Medical Device manufacturing and FDA regulations.Knowledge of ISO 13485, GMP, GAMP 5, and CFR Part 820.Experience with statistical analysis tools (Minitab or equivalent).Exposure to automation systems, MES, or manufacturing process controls. Other Requirements Nagaraj Replacement NPI (New Product Introduction) Engineer with strong expertise in Verification & Validation (V&V) and equipment/process qualification activities including IQ, OQ, and PQ . The candidate will play a key role in introducing new products and manufacturing processes while ensuring compliance with quality, regulatory, and validation requirements.Key ResponsibilitiesLead New Product Introduction (NPI) activities from development through production launch.Plan and execute Verification & Validation (V&V) activities for manufacturing processes, equipment, and systems.Develop, review, and execute