Process Development Engineer
Job ID: JOB-12728
The primary purpose of this position is to focus on the development of processes required to manufacture device designs which are developed by Research & Development with our client, who are a leading Medical Device company.
Position: Process Development Engineer
Reporting to: Senior Process Development Engineer
- Collaborate in a team of engineers focused on the identification, development, and implementation of new processes (within the company or with third parties) required for the manufacture of device designs which are developed by R&D in this company.
- Process validation owner for new processes associated with NPI’s and or process development.
- Ensure that a risk based approach is applied during the development implementation and validation of all processes both within the company and with third party suppliers.
- Ensuring that the principle of Design for Manufacture is central to the R&D process and the devices developed within R&D.
Where appropriate apply Lean Manufacturing principles to the design and implementation of new processes.
- Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with NPI’s and or process development.
- Collaborate with other R&D Teams to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
- Work closely to build effective relationships with other functions in particular Operations, Quality, and Regulatory teams.
- Supplier selection, process development and validation. Support Regulatory Affairs as required with engineering input for process related submissions and renewals prior to and post-initial release of devices to market.
- Ensuring the effective transfer of products from other entities.
- Provide engineering input and support to those responsible for Supplier instigated changes.
- Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
- Responsible for process engineering layout plans and implementation in relation to new processes and production lines.
- Provide engineering input and support for the investigation and resolution of Non-Conformance associated with devices post-release to market.
- Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
Other General Responsibilities:
- Uphold the company’s compliance culture and ensure that compliance requirements are always met.
- Liaise with other manufacturing facilities.
- Support other cross-functional groups to achieve company goals.
- Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
- Ensure that the Code of Conduct is considered in all business matters carried out on the company’s behalf.
Qualifications / Requirements:
- Formal production/engineering qualification and/or relevant experience in the area of NPI and or process development.
- Ideally, candidates should have a minimum of 2 years of process development experience in a Medical Device company
Project management capability
- Strong interpersonal skills and the ability to communicate at all levels of the organization.
- Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
- Proven problem-solving skills.
- Good computer skills including knowledge of Microsoft® Office.
- Excellent organizational and team-building skills.
- High self-motivation.
- Willingness and availability to travel on company business.
For further information on this role in Limerick please contact Johanne Kennedy on 086 440 3725 / email@example.com
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