Design Lead

Requisition
177355
-Posted
11/06/2026

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 Responsibilities Lead 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 Qualifications Bachelor'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 Execution
Equipment Qualification Process Validation Risk Assessments (FMEA)
Root Cause Analysis Experience 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 Qualifications

Experience 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.

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 Responsibilities Lead 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 include:

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 Qualifications Bachelor'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 Execution
Equipment Qualification Process Validation Risk Assessments (FMEA)
Root Cause Analysis Experience in regulated manufacturing environments such as Medical Devices, Life Sciences, Pharmaceutical, or…