Our client a leading MNC is recruiting for a highly motivated and experienced Principle R&D Engineer. You will be responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease.
The 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.
- Lead engineering design, development and support of next generation and current generation transcatheter heart valve products
- 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.
- Work closely with team members and internal partners in Regulatory, Quality, Manufacturing, Marketing and other departments to deliver project objectives
- 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.
- Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects
- Under limited supervision/guidance, compiles, analyses, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
- A bachelor's degree in Mechanical Engineering or Biomedical Engineering is required. An advanced degree is a distinct advantage.
- 9+ years’ experience with BS Degree,7+ years’ experience with MS Degree,4+ years’ experience with PhD
- Relevant mechanical/biomedical engineering experience to include heart valve development, exposure to design of experiments, specification development, and prototyping. Prior experience in an interventional, vascular or cardiac surgery arena a plus, especially involving prosthetic tissues and catheter based technologies.
- Experience in the design and development of valve prostheses and associated processes are required
- 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.
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