Senior Designer - Manufacturing Process

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

Role Overview

A manufacturing process engineer designs, optimizes, and troubleshoots industrial production systems to improve efficiency, quality, and safety

Process engineers bridge the gap between initial product design and daily factory floor execution. They ensure that production lines run smoothly, meet safety and environmental standards, and produce goods at the lowest possible cost

Key Responsibilities

• Process Optimization: Analyze existing manufacturing workflows, reduce cycle times, and eliminate production bottlenecks.
• Troubleshooting: Identify root causes for equipment failures or product defects using data-driven methods like Six Sigma or SPC (Statistical Process Control).
• Equipment Integration: Test, validate, and commission new machinery or automated systems on the production line.
• Standardization: Write clear standard operating procedures (SOPs) and safety guidelines for operators and technicians.
• Cross-Functional Work: Collaborate with quality control, supply chain, and design teams to launch new products efficiently

Skill Requirements

• Develop and execute validation activities for machines (e.g., mills, lathes, multi-axis CNCs) and associated tooling/work holding.
• Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports.
• Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory requirements (ISO 13485, GMP, 21 CFR Part 820).
• Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls.
• Design, execute, and document calibration, metrology, and gauge R&R activities; ensure traceability of measurement equipment.
• Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&R) to demonstrate repeatability, accuracy, and process control.
• Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances.
• Support supplier qualification and acceptance tests for CNC-related components and tooling.
• Provide training and knowledge transfer to operators and maintenance staff on validated mfg processes.
• Ensure compliance with documentation control, record retention, and audit readiness; participate in internal/external audits.
• Maintain equipment lifecycle documentation (maintenance plans, calibration schedules, firmware/software updates) and ensure alignment with change management processes.

Support manufacturing investigations and root-cause analyses related to CNC processes and equipment performance.

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 2026totaled $14.8billion.

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.