Process Engineer
Title: Process Engineer
Location:
Warsaw, IN - OnsiteLong Term Contract - 2+ YearsJD: 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:
- 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
- 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.
- Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls.
- 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.
Required Qualifications
Education:
Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
Experience:
3+years in manufacturing process and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices).Regulatory & Standards: Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ).Communication: Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.