Senior Manufacturing Process Engineer

HCL Technologies Limited; Warren (MI); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) retirement plan

Paid time off

Paid holidays

Job summary

HCL Technologies Limited is seeking a Manufacturing Process Engineer to design, optimize, and troubleshoot production systems, improving efficiency, quality, and safety on the factory floor.

The role covers validating equipment, leading risk assessments, and ensuring compliance with ISO 13485, GMP, and 21 CFR Part 820, while coordinating with QA, regulatory, and design teams to deliver robust manufacturing solutions.

Qualifications

• Develop and execute validation activities for machines and tooling.
• Create and maintain IQ/OQ/PQ protocols and reports.
• Lead risk assessments (FMEA) and ensure regulatory alignment (ISO 13485, GMP, 21 CFR Part 820).
• Collaborate with Manufacturing, QA, Regulatory Affairs, and Equipment Engineering on new machines and change controls.
• Document calibration, metrology, and gauge R&R activities with traceability.

Responsibilities

• Analyze manufacturing workflows to optimize efficiency and reduce cycle times.
• Troubleshoot equipment failures or defects using data-driven methods.
• Test, validate, and commission new machinery or automated systems on the line.
• Write SOPs and safety guidelines for operators and technicians.
• Collaborate with quality, supply chain, and design teams to launch new products efficiently.

Skills

Validation protocols

IQ/OQ/PQ documentation

FMEA

Gage R&R

Regulatory compliance

Change controls

Data analysis Cp/Cpk

Calibration/metrology

Cross-functional collaboration

Tools

Six Sigma

SPC

Job description

HCL Technologies Limited is seeking a Manufacturing Process Engineer to design, optimize, and troubleshoot production systems, improving efficiency, quality, and safety on the factory floor.

The role covers validating equipment, leading risk assessments, and ensuring compliance with ISO 13485, GMP, and 21 CFR Part 820, while coordinating with QA, regulatory, and design teams to deliver robust manufacturing solutions.