Process Engineer: Lean & Automated Manufacturing

CooperVision; Village of Scottsville (NY); On-site; USD 75,000 - 120,000; Full time

Job summary

CooperVision is seeking a process engineer to support manufacturing process development, optimization, and validation from concept to implementation. You will monitor process performance, yield, cost, and product quality while driving continuous improvements in a regulated medical device environment.

The role involves Lean initiatives, data-driven problem solving, and collaboration across engineering and manufacturing teams to transfer new products efficiently and safely.

Qualifications

• High volume manufacturing process engineering and optimization experience.
• Experience defining and optimizing manufacturing processes with Lean manufacturing, continuous improvement, OEE, risk management, and DMAIC.
• Experience with installation and transfer of automated manufacturing equipment into production under medical device regulations.
• Validation experience including FAT, SAT, IQ-OQ-PQ; process characterization; detailed reports.
• Knowledge of QA/QC systems, ideally from medical device/pharmaceutical industry; GAMP and regulatory requirements.
• Health and safety awareness per NFPA/OSHA/CE marking; safe working practices.
• Strong project management and reporting skills with ability to communicate at all levels.
• Motivated team player with ability to lead projects and deliver sustainable solutions.
• Experience with IT systems hierarchies - ERP, manufacturing control systems, SCADA, PLC.
• Proficiency in data analysis using Minitab and advanced Excel.

Responsibilities

• Supports installation, development, and validation of manufacturing processes from concept to implementation.
• Monitors process performance, yield, cost, and product quality in manufacturing.
• Identifies root causes, evaluates data, and implements best solutions.
• Troubleshoots issues across manufacturing disciplines and provides corrective actions.
• Drives improvements in yield, cost, and product quality across operations.
• Maintains production documentation reflecting current GMP/cGMP standards.
• Supports validation activities including protocols and reports; ensures regulatory compliance.
• Assists in transferring new products/processes into manufacture for efficient startup.
• Leads Lean initiatives and improvement events using 6S, VSM, Kaizen, Visual Mgmt, Poka-yoke, 3P.
• Conducts space optimization analyses and maintains equipment/manufacturing layouts.
• Assesses business impact of actions to protect CooperVision's position.

Skills

Lean manufacturing

DMAIC

Six Sigma

Process validation

Regulatory requirements

Data analysis

Education

B.S. in Mechanical or Manufacturing Engineering

Lean Manufacturing Green Belt or higher

Tools

Minitab

Excel

SolidWorks

AutoCAD

ERP

SCADA

Job description

CooperVision is seeking a process engineer to support manufacturing process development, optimization, and validation from concept to implementation. You will monitor process performance, yield, cost, and product quality while driving continuous improvements in a regulated medical device environment.

The role involves Lean initiatives, data-driven problem solving, and collaboration across engineering and manufacturing teams to transfer new products efficiently and safely.