Job Description

Job Summary

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

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.

Other Requirements