Process Development Engineer
Process Development Engineer
CREGG Recruitment are currently hiring a Process Development Engineer to work onsite with a leading medical device multinational client in Cork. Call Stephen Coen 0861030418 Email: stephencoen@cregg.ie
The Process Development Engineer will support the introduction of new microcatheter line that is to automate the process.
You will be responsible for delivering innovative and practical manufacturing solutions for the manufacture of the new product.
You will also be responsible for delivering an automated handling system to produce this in a high volume environment.
Key responsibilities:
- Provide a link between R&D team and Cork site to technically understand requests and develop manufacturing process to meet needs.
- Support R&D activity during the product design phase.
- Manage a process introduction while mitigating product and process risk, increasing yields and improving efficiency.
- Working with vendors to develop and prove out an automated system for production.
- Managing the introduction of the designed equipment into a production environment.
- Lead the process introduction through validation works ensuring all stakeholders needs are met and all inputting departments have completed their roles effectively and on time.
- Plan for a process introduction with a key interest in budget and timelines ensuring these do not drift while ensuring quality of the product is not impacted.
- Applying innovative problem solving to address process, safety, product, timeline, budget risks.
- Identify and implement new technologies where needed to support chemical processes.
Qualifications:
- Bachelor’s degree or higher in Mechanical or a related Engineering field is required
- 5 years' proven experience in medical devices
- Previous experience in high volume equipment development is a help but not essential.
- Experience developing processes through risk and validation streams.
- Key areas of interest will be Validation, risk management, change management, statistical analysis, process characterization
- Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
- Experience participating in multi-functional teams and NPD design transfer to manufacturing
