NPD Process Development Engineer with Lean Manufacturing experience required to develop new & existing manufacturing processes by medical devices multinational in Galway
Responsibilities:
- Work as part of the NPD team to drive product and process improvements
- Manage new designs through product lifecycle into Manufacturing
- Work closely with Subject Matter Experts in the business to ensure all new product fit within existing manufacturing capability
- Work closely with Lean and Operations teams to ensure that any new processes developed meet world-class manufacturing standards
- Display customer focus always and be accountable for quality and timeliness of own work
- Manage a variable workload across different projects to meet NPD requirements
- Design and introduce manufacturing processes for new products to meet the demands of productivity and quality
- Ensure that complete and effective validations are carried out on all processes before transferring to manufacture including IQ, OQ, PQ & PPQ
- Identify and put in place permanent and effective technical / system solutions to problems
- Maintain high quality / compliance standards in line with Medical Devices manufacturing requirements
- Applying Lean principles to identify and develop improvements that increase key process metrics of yield, throughput and productivity
- Investigate new process technologies and evaluate potential competitive advantage and the cost-benefit of introduction
- Manage external relationships with technology providers / suppliers
- Ensure that all Health, Safety and Environmental requirements are fulfilled
- Level 8 Engineering Degree, or equivalent qualification
- 3 – 5 years’ experience in a similar role
- Knowledge of ISO and FDA compliance with an emphasis on validation
- Knowledge of Six-Sigma methodology, problem-solving tools and Lean Manufacturing principles
- Knowledge of equipment, process and product validation processes, ability with statistical data analysis
- Strong mechanical background
- Experience in the development of test methods and associated product testing
- Strong technical background and capabilities
- Motivated to work on own initiative and the ability to make and implement decisions
- Excellent communication, planning and organizational skills
- A demonstrated ability to solve problems with innovative and cost-effective solutions
- Computer literate and familiar with all Office software packages
- Proven track record of excellent timekeeping & attendance is essential
