Our client has an exciting opportunity to join their growing team for an R&D Engineering Manager. The position is permanent and based in our clients Galway facility, this will be a Hybrid role. We are looking for someone who has experience in the development and transfer to manufacture of medical devices. The role will involve working with a cross functional/cross site team to ensure end user and regulatory requirements are met. The candidate will work across all stages of device development. This includes prototyping, bench model development, DFM and manufacture support, clinical builds, clinical trial support and all relevant activities on the path to commercialisation.
POSITION RESPONSIBILITIES / ESSENTIAL FUNCTIONS
- Lead and be an integral part of the team tasked with the development process from concept generation through to design verification and validation through to FDA clearance.
- Assist in the development of intellectual property generated by development activities
- Participate in trials with physicians to provide clinically relevant feedback on product designs
- Provide technical feedback during frequent technical contact with customers to optimise product design
- Support the maintenance of product files and other relevant documentation to comply with quality standards
- Compile project plans and lead the R&D team to develop the device in accordance with planned activities, budget and timelines.
- Spec out full lab test plan, including the identification of equipment necessary to support the development and manufacture of the company’s catheter based product.
- Lead test method development and validation for new and existing test methods.
- Identify, analyse and reduce potential design limitations (DFMEA, PFMEA).
- Prepare and review technical protocols and reports by collecting, analysing and summarizing information.
- Drive the design transfer of products from development stage to manufacture.
- Help define and develop manufacturing specifications.
- Create, communicate and execute research programs and project plans to meet project deadlines.
- Formulate new, innovative approaches to solve technical problems on a consistent basis.
- Communicate key information and recommendations to influence technical decisions and strategy.
- Engage in a continuous program of learning to broaden knowledge in technical/engineering expertise. • Experience in coordinating and leading Design Reviews and the compilation of associated documentation • Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities
- Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements
- Proven experience of minimally invasive Medical Device design, development and manufacturing
- Proven experience in leading teams performing FMEA’s, verifications and validations for medical devices products and processes.
- Knowledge and experience with Medical Device sterilisation processes, specifically gamma and EtO sterilisation Working knowledge of biocompatible metallic and/or polymer materials
- Availability to participate in limited travelling to meet with customers to conduct scheduled reviews
QUALIFICATIONS AND EXPERIENCE
- A minimum of a Bachelor’s Degree in Life Sciences or Engineering discipline combined with 8+ years medical device product development / manufacturing experience.
- Higher level qualification (MSc, PhD) in medical device technology is preferred.
- Demonstrated experience in design transfer from R&D to manufacture.
- Demonstrated design and development skills with design for manufacture perspective.
- Demonstrated experience in the design verification and validation process.
- Demonstrated experience in regulatory preclinical and clinical trials process.
- Competence in technical writing to translate to regulatory documentation.
- Ideally the candidate would have experience in fluidic transfer and electronics.
- Experience in 3D modelling, ideally Solidworks.
- Experience with engineering tools such as DOE using Minitab.
For a confidential and in depth discussion on the role please contact Chris O Toole.