Research and Development Engineer
Galway
Permanent
€60-€65k
€60-€65k
Overview:
Our Client is an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build up of fluid in the body as a result of late-stage cancers. Over the past 5 years the founders, who are passionate about developing patient-centred products, have built strong and lasting relationships with partners that have helped fast-track the development of their device.
As a result of this success and momentum they are hiring an R&D Engineer to join the team based in Galway.
R&D Engineer:
Ideally you will thrive in a multidisciplinary start-up environment. We are looking for candidates that are curious, have a strong work ethic are motivated by the positive influence your work will have on the quality of life of the customers. As an R&D Engineer you will report to the R&D Project Lead and will get the opportunity to apply your engineering knowledge in areas such as design, test method development and validation, CAD and design controls during this exciting time as they bring their products to market. This is a high paced start up moving from Phase 1 to Phase 3 within the next 18 months working closely with their Contract Manufacturer. The successful candidate will be comfortable working closely with senior management and other stakeholders within the organization and will effectively deliver product solutions which benefit our customers.
The successful candidate will be responsible for:
An honours Bachelor's Degree in an Engineering or related discipline is required. Length of Experience: A minimum of 5 years product development in medical device design is required. Specialized Skills/Technical Knowledge:
Our Client is an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build up of fluid in the body as a result of late-stage cancers. Over the past 5 years the founders, who are passionate about developing patient-centred products, have built strong and lasting relationships with partners that have helped fast-track the development of their device.
As a result of this success and momentum they are hiring an R&D Engineer to join the team based in Galway.
R&D Engineer:
Ideally you will thrive in a multidisciplinary start-up environment. We are looking for candidates that are curious, have a strong work ethic are motivated by the positive influence your work will have on the quality of life of the customers. As an R&D Engineer you will report to the R&D Project Lead and will get the opportunity to apply your engineering knowledge in areas such as design, test method development and validation, CAD and design controls during this exciting time as they bring their products to market. This is a high paced start up moving from Phase 1 to Phase 3 within the next 18 months working closely with their Contract Manufacturer. The successful candidate will be comfortable working closely with senior management and other stakeholders within the organization and will effectively deliver product solutions which benefit our customers.
The successful candidate will be responsible for:
- Supporting design and development of our product including concept development, high-level design feasibility, prototype development, detailed design and DFM, design verification/validation activities.
- Application of new and existing technologies, materials and processes to deliver the optimum product design ensuring excellent standards of performance.
- Introduce/develop new equipment and production processes as required for any new manufacturing techniques.
- Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes. Including part and material specifications, technical drawings and engineering protocols/reports for support of FDA and EU MDR submission.
- Conducting sophisticated data analysis and developing detailed reports documenting results, conclusions and recommendations.
- Using Engineering problem solving tools to execute root cause investigations.
- Engaging with Vendors and suppliers on a regular basis to ensure efficient delivery of services.
- Participating in test method development and test method validation.
- Monitoring of equipment maintenance calibration and upkeep of the Engineering lab.
An honours Bachelor's Degree in an Engineering or related discipline is required. Length of Experience: A minimum of 5 years product development in medical device design is required. Specialized Skills/Technical Knowledge:
- Experience in medical device design principles, material selection, design concept validation and test method development essential.
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, tolerance-analysis and design-for-manufacturing principles. •
- Experience of working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
- Proficiency with CAD software (Solidworks) is required.
- Experience with lab equipment such as UV bonding equipment, microscopes, tensile testing machines.
- Experience of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements is required.
- Strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
- Excellent problem solving, decision making and root cause analysis skills are desired (DMAIC)
- Proficiency with MS Office suite is required.
- Proficiency with statistical software (Minitab) is desired.
- Practical knowledge of FEA Software (Ansys) is desirable