Design Lead
United States
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Job Description
Design Lead
Santa Clara, California

Job Summary

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 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.
Maximum Salary (US): 
Minimum Salary (US): 
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Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2026 totaled $14.8 billion. 

 

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.