Principal R&D Tissue Engineer
Job ID: JOB-11940
Principal R&D Tissue Engineer
My client in Galway is seeking an experienced Principal R&D Tissue Engineer to join their innovative R&D team. Be a part of one of the most exciting areas of growth within the medical device!
A highly motivated and experienced Principal R&D Engineer to join the Galway Structural Heart R&D team. The successful candidate will be responsible for leading heart valve tissue and surrogate material development activities. Responsibility for the delivery of performance testing at a finished product and subassembly level is a pre-requisite but is also extended to include research, design, and development of novel test methods.
- Successful candidate will work independently, or as a member of a team within a dynamic New Product Development organisation specialized in transcatheter heart valve system development for commercialization in all major global healthcare markets.
- Responsibility to drive research, design, and development of novel tissue types and surrogate materials for application in Structural Heart device design.
- Responsible for heart valve tissue testing at finished product and subassembly level.
- Responsibility to include research, design, and development of novel test apparatus and test methods.
- Provides technical guidance to support personnel, including engineers and technicians and assures that their work is performed properly.
- Provide global training, audit support, technical guidance / trouble shooting cross – site on Tissue controls and compliance to global standards
- New Projects and Commercial Device Support
- Acts as project engineer to manage the scope, schedule, and resources for assigned projects. Monitors project progress and regularly reports progress to manager.
- Communicates project status to cross-functional colleagues throughout organization
- Work closely with team members and internal partners in R&D, Regulatory, Quality, Pre- Clinical, Clinical, Manufacturing, Marketing and other departments to deliver project objectives
- Qualifies and documents testing and methodologies in support of regulatory filings.
- Support R&D, manufacturing and quality groups for improvements to existing products in the areas of quality enhancement, product cost and product performance.
- Lab management (analytical and mechanical testing)
- Technical leadership of Structural Heart tissue and materials lab, including management of project execution, laboratory spend and inventory.
- Assess and implement appropriate tissue and materials testing at component / finished goods level
- Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review and maintenance of associated training records.
- Manage equipment calibration and qualification as required.
- Manage completion of documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
- Prepare or direct the compilation, analysis, and reporting of test and research data to establish performance standards for newly designed or modified products, processes, and materials.
- Ensure all testing is carried out as defined in the Quality System.
Global Lead for Tissue
- Develops and implements actions to establish tissue testing as a core competency
- Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
- Coordinate with outside consultants to ensure lab and R&D activities stay current and aligned with future trends
- Provide global training, technical guidance / trouble shooting cross – site on Tissue controls and compliance to global standards
- Recommends and submits ideas for patent protection/coverage.
- Contributes to global standards development programs relating to MOAO, in addition to novel materials and processes
- Lead the development of alternative tissue processing methods
- Maintain technical knowledge current with advancing technology related to cardiac valve prostheses and associated technologies in addition to knowledge of competitive technologies
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers related to materials, manufacturing processes and design
- Fully support the Quality Policy by building quality into all aspects of the incumbent’s work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent’s position and documenting that training).
- Post-graduate degree in Engineering or related discipline, with 5+ years industrial experience in tissue development, tissue testing or materials development ((familiarity with medical devices with derivatives of animal origin (ISO 22442), liquid chemical sterilization (ISO 14160), viral safety (ISO 22442-3)).
- Specialization in product or process development for the treatment of aortic valve disease or other applicable structural heart technology especially involving development of tissue based technologies.
- Experience in application of analytical techniques, including various forms of spectroscopy (NMR, IR, UV-Vis), separation techniques (HPLC, GC), thermal analysis (DSC, TGA), viscosity and osmolality determination, and water analysis.
- Strong ability to interact and collaborate with a diverse range of colleagues including manufacturing, new product development, preclinical and clinical staff.
- Experience in the design and development of tissue materials and processes for application in valve prostheses and associated processes are required
- Understanding and extensive application of technical principles, theories, and design concepts in implantable products
- Good understanding of the Human Anatomy and cardiovascular physiology is strongly desired
- Broad, working knowledge of manufacturing process for medical devices, design control and Quality Systems.
For further information on this role in Galway please contact Anna McGowan on 0864667369 / email@example.com
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