Our client a major multinational here in Galway are seeking applications from a suitably qualified and experienced Senior R&D Engineer to join them on an initial 12 month contract.
The Role:
You will provide technical direction and system level understanding and expertise regarding design, development and sustaining of transcatheter heart valve devices. You will provide technical guidance to a dynamic interdisciplinary team of engineers from project concept, through product development and post commercialisation.
Responsibilities:
- Lead engineering design, development and support of next generation and current generation transcatheter heart valve products
- Proficient in the application of design tools, process factors and performance outputs required to drive heart valve concepts
- Apply Mechanical and Biomedical Engineering knowledge to the design, development and assessment of prosthetic heart valves
- Create/develop technical capabilities and expertise related to the design and testing of heart valve Technology
- Develop hydrodynamic and fatigue test methods and characterisation techniques to evaluate performance of valve prototypes
- Perform necessary tasks to successfully translate designs from proof of concept through commercialization including:
- Ensure review of existing research, device concepts and data.
- Generate valve design concepts, build and evaluate prototypes.
- In conjunction with product planning / marketing, collaborate with leading physicians and experts for the purpose of identifying and clarifying customer needs, plans, goals, and progress.
- Prepare trade-off studies and implement alternative approaches to mitigate schedule delays and identify areas that require additional investigation.
- Solve problems at the component through system level
- Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports
- Performs data analysis (statistical and practical) and develops appropriate action plans based upon such analysis.
- Participate in the specification and direct completion of specific verification/validation testing and analyses required that satisfy both regulatory and internal requirements.
- Document concepts, designs and design modifications in accordance with internal policies, industry standards and FDA requirements.
- Coordinate with outside consultants and clinicians to ensure testing and analyses required to fully qualify and verify device designs are appropriately representative of expected use conditions.
- Key part of both initial scope development and final design verification
- Work closely with team members and internal partners in Regulatory, Quality, Manufacturing, Marketing and other departments to deliver project objectives
- Support operations improvement activities.
- Review associated justifications and links to clinical performance.
- Provide clear and regular technical direction to personnel assigned to a project
- 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
- Support manufacturing and quality groups for improvements to existing products in the areas of
- quality enhancement, product cost and product performance.
- Prepare or direct the preparation of oral and written reports of current status, progress and status of
- total project, as required by the customer, project or department Management.
Requirements:
- Level 8 Bachelors Engineering Degree (240 credits) or related discipline, with 6+ years industrial experience in heart valve design or delivery system development advantageous.
- Position requires relevant mechanical/biomedical engineering experience, exposure to design of experiments, specification development, and prototyping.
- Technical Project lead experience
- 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 valve prostheses and associated processes are desired
- Experience with medical device testing of vascular prostheses and/or catheter delivery systems a plus
- 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
- In depth understanding of fluid mechanics and computational fluid dynamics (CFD) particle image velocimetry is strongly desired
- Broad, working knowledge of manufacturing process for medical devices, design control and Quality Systems.
For more information or a confidential discussion about this role please contact Michelle McInerney
michelle.mcinerney@collinsmcnicholas.ie
091 706 717