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
Responsibilities:
- Collaborate in a team of engineers focused on identification, development, and implementation of new processes required for the manufacture of device designs which are developed by R&D
- 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 .
- 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.
- 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 Conformances 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 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.
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 process development experience in a Medical Device company
- Project management capability
- Strong interpersonal skills and the ability to communicate at all levels of the organisation.
- 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 organisational and team building skills.
- High self-motivation.
This role can be remote with one day a week onsite .
