Process Engineer Senior
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Job Location:
Gilbert, AZ - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Summary:
At CooperVision a division of CooperCompanies were driven by a unifying purpose to help people to experience lifes beautiful moments. We are connected through our shared values - dedicated innovative friendly partners and do the right thing. As a leading global manufacturer of contact lenses we are committed to helping improve the way people see each day. Through our diverse lens portfolio we tackle the toughest vision challenges including astigmatism presbyopia and childhood myopia. We offer the most complete collection of spherical toric and multifocal products available enabling us to fit 99% of all contact wearers. Learn more .
Provides technical expertise in supporting a variety of manufacturing processes to achieve the targeted performance levels for the overall site and wider business objectives. Provides manufacturing process and project engineering support including process development validation and continuous improvement activities. Supports the wider business in the introduction of new products and automated processes into manufacturing working closely with Manufacturing engineer global support groups.
Responsibilities
Essential Functions & Accountabilities:
Leads initiatives for 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.
Leads corrective action through troubleshooting activities where issues arise across various manufacturing disciplines providing corrective action to resolve disruptions.
Leads cross-functional teams through formal problem-solving events resolving systemic issues utilizing Corrective Action Preventive Action (CAPA) methodology.
Seeks to identify areas for Improvement in process yield cost and product quality.
Leads improvement projects and the implementation of improvements across manufacturing operations as appropriate.
Helps develop and maintain production related documentation ensuring said documents are accurate up to date and reflect current Good Manufacturing Practices
Leads process and product validation activities including the construction and delivery of validation protocols and arising reports. Ensures that the validation process and procedures are fit for purpose and compliant with current regulatory requirements.
Manages the receiving of new products and processes into site manufacturing to ensure the most efficient transfer.
Leads manufacturing improvement events driving Lean initiatives to improving processes utilizing various toolbox items. (6S value steam mapping Kaizen Visual Management Poka-yoke etc.)
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.
Revise / create SOPs and WIs related to the manufacturing process.
Travel Requirements:
- Minimal travel may be required
Qualifications
Qualifications
Knowledge Skills and Abilities:
Core competency Leadership Level
Leadership motivation and management
Professional competence & knowledge
Problem solving
Planning and organizing
Continuous improvement
Teamwork
- Knowledge and experience working in a regulated medical device environment to ISO 13485 and/or FDA Code of Federal Regulations (CFR) Title 21 Part 820. Preference is experience in contact lens design and manufacturing environments.
- Knowledge and experience of process design and development equipment automation design development installation and validation.
Proficient in the definition and optimization of manufacturing processes including creation of appropriate documentation with demonstrated results in the following areas:
Leanmanufacturing
Continuousimprovement
OEE
RiskManagement
DMAIC
Builds and maintains close working relationships with manufacturing local an global functional support teams to create and deliver workable and sustainable solutions.
Demonstrates a clear understanding of the demands within the business and the need to supply sustainable engineering solutions.
Highly competent in various automation disciplines with demonstrated success in transfer and install of manufacturing equipment into production adhering to medical device regulations.
Demonstrated validation expertise including FAT SAT IQ-OQ-PQ process characterization and proven reporting capability.
Competent in Quality Assurance and Quality Control systems ideally from medical device/pharmaceutical industry and appropriate regulatory requirements.
Health and Safety experience in respect of safe working practice use of equipment/guarding mechanical handling NFPA/OSHA or CE marking.
Proven project management and reporting skills with the ability to communicate effectively at all levels. Demonstrated experience as a first line leader managing complex projects.
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.
Demonstrated analytical and problem-solving skills Process Flow Diagrams FMEA / risk assessments Lean Six Sigma Design of Experiments and Statistical Process Control.
Demonstrated use of Minitab or equivalent and/or advanced Excel proficiency supporting data analysis.
CAD experience preferred Solidworks and AutoCAD platforms a plus.
IT proficient with Microsoft applications Outlook Office Project etc...
Work Environment:
- Generally works in a closed environment in office conditions with moderate level of noise and controllable changes of temperature
- Needs to stand walk and may be seated for a long period of time
- Uses hands to feel handle and reach
- Performs light physical effort with little exposure to adverse conditions
- Works with a personal computer and programs to prepare documents or reports
- 60% Manufacturing floor 40% Desk
Experience:
- At least 5 years of experience as an engineer working in a manufacturing process or equal experience in managing technical projects in medical device manufacturing environment.
Education:
Bachelors degree in mechanical or manufacturing engineering or a related fieldor equivalent experience in medical device manufacturing environment.
- Lean Six Sigma certification preferred.
Required Experience:
IC
Key Skills
About Company
Live Brightly. Our daily and monthly soft contact lenses are designed with your health and comfort in mind. For every eye, every person, and every day.
