Design Lead: NPI & V&V for Regulated Med Devices

HCL Technologies Limited; Santa Clara (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

HCL Technologies Limited is seeking an NPI engineer in Santa Clara, CA, with strong V&V, IQ/OQ/PQ protocol development, and equipment qualification experience. You will lead New Product Introduction activities and ensure compliance with GMP, FDA, ISO 13485 standards.

The role involves cross-functional collaboration across Manufacturing, Quality, R&D, Process Engineering, and Supply Chain to drive successful product transfers and continuous improvements.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Biomedical, Industrial Engineering or related field.
• 6+ years in NPI, Manufacturing, Validation or Quality Engineering.
• Hands-on V&V, IQ/OQ/PQ protocol development and execution; equipment qualification.
• Process validation; risk assessments (FMEA); root cause analysis.
• Experience in regulated manufacturing environments (Medical Devices/Life Sciences/Pharma).
• Familiarity with GMP, FDA, ISO 13485; strong documentation skills.

Responsibilities

• Lead NPI activities from development through production launch.
• Plan and execute V&V activities for processes, equipment, and systems.
• Develop and execute IQ/OQ/PQ protocols; prepare validation documentation.
• Collaborate with Manufacturing, Quality, R&D, Process Engineering, Supply Chain.
• Support ECOs, process improvements, and continuous improvement initiatives.
• Participate in design reviews, risk management (FMEA) and product transfer.

Skills

V&V

IQ/OQ/PQ

FMEA

Root Cause Analysis

NPI

Regulatory Compliance

Project Coordination

Education

Bachelor's degree (Mechanical/Manufacturing/Biomedical/Industrial)

Tools

Minitab

Job description

HCL Technologies Limited is seeking an NPI engineer in Santa Clara, CA, with strong V&V, IQ/OQ/PQ protocol development, and equipment qualification experience. You will lead New Product Introduction activities and ensure compliance with GMP, FDA, ISO 13485 standards.

The role involves cross-functional collaboration across Manufacturing, Quality, R&D, Process Engineering, and Supply Chain to drive successful product transfers and continuous improvements.