Our client, a well funded and high potential start up based in Galway, are seeking a highly experienced, skilled and motivated Senior R&D Engineer to join their dynamic team. The successful candidate will provide hands-on technical expertise to support the structured design and development process, including device design, development of manufacturing processes and test methods, and support of all validations. It is an opportunity to be part of a highly motivated and ambitious team and work on projects from early stage through to commercialisation. If you are suitably qualified and excited about making a lasting impact in maternal health, then we would love to hear from you.
Your Impact:
Provide technical expertise to all design and development activities, in a structured product development environment. Provide technical support to the establishment of the manufacturing, packaging, labelling and sterilisation processes, working in tandem with the contract manufacturer.
Liaise accordingly with the contract manufacturer and all suppliers, as required, to finalise material/product specifications, implement appropriate inspections/testing and provide timely resolution to any technical issues identified.
Design, develop and validate appropriate bench-top test methods for the company’s products.
Support the testing activity conducted externally, providing engineering guidance as needed.
Conduct and document all Preventative Maintenance and Calibrations on internal equipment.
Document all engineering activity appropriately, using the Company’s approved Standard Operating Procedures (SOPs) and associated templates.
Any additional duties upon the request of the supervisor or management team.
Travel in-country, as required, to support all validation activities.
Core Competencies and Skills Required:
Excellent knowledge and application of technical and engineering principles in a medical device environment.
A competent understanding and working knowledge of all areas of medical device design, development, manufacturing, testing and validations.
Proficiency in 3D modelling.
Strong aptitude for problem-solving and conducting root cause investigations.
Excellent technical writing skills, with good analytical, detailed, and thorough work ethic.
Ability to conduct technological research and analyses.
Good communication and interpersonal skills.
Strong independent worker with ability to work with a cross-functional team.
Adaptability to be able to work in multiple areas of a start-up company.
Experience and Educational Qualification Requirements:
3rd Level degree in an engineering or technical discipline.
A minimum of 5 years’ experience in a technical/design/engineering or equivalent discipline.
Previous experience in an environment registered to ISO13485, 21CFR820 or equivalent.
For a detailed conversation on the role and organisation please contact Amy Newell
amy.newell@collinsmcnicholas.ie