Overview
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 in Cook Medical.
Reporting to: Team Lead, Research and Development
Responsibilities
- Collaborate in a team of engineers focused on identification, development, and implementation of new processes (within Cook Medical or with third parties) required for the manufacture of device designs which are developed by R&D in Cook Medical.
- 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 Cook Medical 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 Cook Medical 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 tonew 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 Cook Medical compliance culture and ensure that compliance requirements are always met.
- Liaise with other Cook 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 Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Qualifications
- Bachelor’s degree is required, preferably in engineering or a related field.
- Minimum of 3 years’ relevant experience is desired.
- 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.
- Willingness and availability to travel on company business.
About Cook Limerick
Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets.
Research and Development in Limerick
Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world.
Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch.
The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies.
Our employee benefits include:
- Hybrid Work Model
- Company sponsored Defined Contribution pension scheme
- Medical Health Insurance cover for you and your immediate family
- Life Assurance and Income Protection cover
- Educational Assistance
- Performance related Bonus
- Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
- Fully equipped gym on site
- 39-hour week with flexible start & finish times
- Paid time off to participate in volunteer activities
- Free parking
- Subsidised restaurant
- Sports & Social club
#LI-Hybrid