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Job ID: JOB-13645
We are seeking applications from a suitably qualified and experienced Senior R&D Engineer to join us on a Defined Term basis (12 months).


Job Purpose

The successful candidate will provide technical direction and system level understanding and expertise regarding design, development and sustaining of transcatheter heart valve devices. This candidate 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.

What we’re looking for:

• 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.

Johanne Kennedy

JOB-13645

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