Process Engineer

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.

• 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.

Knowledge, Skills and Abilities:

• 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.