Manufacturing Process Engineer – Experienced Manufacturing Engineer required for leading multinational medical device manufacture in Ireland.
- The work involves producing high quality goods efficiently using the most cost-effective methods and with the aim of reducing the impact of production on the environment.
Support the design, review and integration for new equipment projects as well as new equipment installation
- Review products to determine root cause of potential manufacturing defects then develop and implement effective corrective actions.
- Support and execute SAT testing on behalf of the end user
- Manage the successful scale up and commercialisation of this new process ensuring that target yield, capacity, throughput time and productivity are achieved
- Conceptual design during quotation period,
Participate on and lead project teams, provide technical support and make informed decisions on hardware and architecture selection
- Monitor and analyses opportunities for the development of new or improved tools for process improvement activities
- Ability to successfully manage multiple projects at once.
- Adhering to plant EHS policies/procedures, report hazardous conditions or risks, follow department EHS rules, and PPE requirements.
- Follow Good Manufacturing Practices (GMP’s), ISO 13485 regulations and Good Housekeeping procedures.
- Perform studies of existing conditions related to the problem presented and analyze required changes to achieve increased production output and/or reduce product/process defects and waste.
- Ability to redesign existing machine components to improve performance. This may include adding or modifying sensors, brackets or stations. This would also include any associated machine guarding to ensure employee safety.
- Provide weekly/monthly OpEx updates including key metrics to the organization, and maintain Lean manufacturing visuals throughout the focus factory.
- Use and understand Statistical based software and Quality tools (i.e., Process Maps, C&E Matrix, FMEA, and Design of Experiments) for warranting process changes or continuous improvements.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
- Compose and execute validations and changes per the change control process.
- Work with other professionals, such as accountants and human resources personnel, to manage budgets and the recruitment of junior engineers;
- Tendering for new equipment to ensure the highest quality at the best price;
- Supervising technicians and sub-contractors and ensuring effective communication in order to avoid errors;
- Organize plant start-up and shut-down schedules to ensure minimum loss of production time and profits;
- Liaising with the research and development department to ensure the company is at the forefront of ground-breaking research, and to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
DESIRED SKILLS AND EXPERIENCE
- Minimum 3 years relevant and recent experience in project / process engineering in a highly regulated environment.
- Knowledge of GAMP5 or other Validation methodology
- Degree qualification in a relevant field
- Strong Analytical and Technical problem solving skills
- Experience with braiding equipment and it’s process is preferable
- Experienced in Product Transfers and Manufacturing process set-up and scale-up.
- Self-motivated person that can work individually and lead team projects.
- Previous experience working as a Manufacturing Engineer within a Medical Device or Pharmaceutical environment.
- Demonstrates strategic thinking and drives continuous improvement in day-to-day activity.
- Ability to develop system documentation
- Previous experience with Audit activities and participation.
- Extensive PLC programming and applications experience, along with knowledge of OEM equipment and industrial automation
- Strong communicator and proven ability to work within a team environment and maintain focus on key objectives.
- Technical proficiency in all modern Automation & Process technologies and applications
- Competent in the understanding and application of Six Sigma and Lean Manufacturing Techniques
- Technical knowledge of polymer materials used in the manufacture of medical devices
- Sound technical engineering approach to project management and problem solving
- Experienced with all the Microsoft Office software applications for generating office documents, spreadsheets, project plans, etc.