Senior Designer - Manufacturing Process

HCL Technologies Limited; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Sapsf is seeking a Senior Designer - Manufacturing Process to design, validate, and optimize industrial production systems. You will bridge product design with factory execution, ensuring safety, quality, and cost efficiency on the plant floor.

Responsibilities include optimizing workflows, validating new equipment, writing SOPs, and collaborating across QA, regulatory, and design teams to launch products efficiently.

Qualifications

• Experience in validation of manufacturing equipment and processes.
• Familiarity with ISO 13485, GMP, and 21 CFR Part 820.
• Ability to develop SOPs and safety guidelines.
• Experience with Six Sigma or SPC data-driven methods.

Responsibilities

• Analyze workflows to reduce cycle times and remove bottlenecks.
• Test, validate, and commission new machinery on the production line.
• Write SOPs and safety guidelines for operators.
• Collaborate with QA, regulatory, and equipment engineering to qualify machines and implement change controls.
• Provide training on validated processes.
• Support audits and documentation control.
• Maintain equipment lifecycle docs and calibration schedules.

Skills

Validation planning

CAPA management

FMEA

Statistical data analysis (Cp/Cpk, G&R

Regulatory compliance (ISO 13485, GMP,

Tools

Calibration equipment

Job description

Career Opportunities: Senior Designer - Manufacturing Process (162213)

Requisition ID162213-Posted09/28/2026

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

Role Overview

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

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.