Responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease. 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.
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, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
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.
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
Position requires 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.