Process Engineer

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

Provides manufacturing process and project engineering support including process development and continuous improvement activities. Supports the wider business in the introduction of new products and automated processes into manufacturing.

Responsibilities

• Supports the installation, development, and validation of manufacturing processes from concept to implementation.
• Provides on-going support and monitoring to the manufacturing organization in achieving objectives in respect of process performance, yield, cost, and product quality.
• Identifies process problems to gain root cause, evaluating data from a variety of sources, formulates alternative solutions, selects, and implements the best solution.
• Undertakes troubleshooting activities where issues arise across various manufacturing disciplines providing corrective action to resolve disruptions.
• Seeks to identify areas for Improvement in process yield, cost, and product quality. Undertakes improvement activity and the implementation of improvements across manufacturing operations as appropriate.
• Helps develop and maintain production related documentation, ensuring documents are accurate, up to date and reflect current GMP (cGMP).
• Supports process and product validation activities including the construction and delivery of validation protocols and reports. Ensures that the validation process and procedures are fit for purpose and compliant with current regulatory requirements.
• Assists in the receiving of new products and processes into manufacture to ensure the most efficient transfer.
• Supports manufacturing improvement events driving Lean initiatives to improving processes utilizing various toolbox items. (6S, VSM, Kaizen, Visual Mgmt, Poka-yoke, 3P, ...)
• Conduct analysis for space optimization and maintains equipment / manufacturing layouts.
• Always considers the potential business impact of specific actions and decisions for the company and consistently directs efforts to preserve and enhance its business position.

Travel Requirements

• Minimal travel may be required, estimated at 1-2 weeks per year.

Qualifications

• High volume Manufacturing process engineering and optimization experience.
• Experienced in defining and optimization of manufacturing processes, including creation of appropriate documentation, with demonstrated results in the following areas: Lean manufacturing, Continuous improvement, OEE, Risk management, and DMAIC
• Experienced in the installation and transfer of automated manufacturing equipment into production according to medical device regulations.
• Validation experience including FAT, SAT, IQ-OQ-PQ, process characterization, producing detailed reports.
• Knowledge of Quality Assurance and Quality Control systems, ideally from medical device/pharmaceutical industry, GAMP and appropriate regulatory requirements.
• Health and Safety awareness in respect of safe working practice, use of equipment/guarding, mechanical handling, NFPA/OSHA or CE marking.
• Good project management and reporting skills with the ability to communicate effectively at all levels.
• Motivated team player with a can-do attitude having the ability to effectively lead projects and improvement activities, delivering workable and sustainable solutions.
• Experience of IT systems hierarchies - ERP, Manufacturing control systems, SCADA, PLC.
• Proven analytical and problem-solving skills, PFD, FMEA / risk assessments, Lean Six Sigma, Design of Experiments and Statistical Process Control.
• Experienced in the use of Mini tab and/or advanced Excel proficiency for data analysis is preferred.
• CAD experience preferred, Solidworks and Autocad platforms a plus.
• IT proficiency Microsoft applications, Outlook, Office, Project, etc...

Work Environment

• Flexibility required in supporting CooperVision sites and activities, supporting additional working when required to meet the needs of the business.
• Based in an office environment and working within manufacturing and areas of specified environmental cleanliness, fast moving machinery, materials and products.

Experience

• 2-5 years’ experience in engineering and manufacturing support.
• Knowledge in process design and development, process control and monitoring.
• Experience with six sigma and lean manufacturing a plus.
• Experience with medical device manufacturing environments or other highly regulated environments a plus.

Education

• B.S. in Mechanical or Manufacturing Engineering or related engineering discipline; or an equivalent combination of education and experience.
• Practitioner in Lean Manufacturing and / or Six Sigma - Green Belt or above is preferred.

The anticipated base pay range for this position is $75,000 to $120,000 annually, depending on qualifications, skills, experience, and other business-related factors.

About Us

CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and an employee-centric culture fuel a deeply engaged, high performing organization.

CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That's a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.