Job Purpose Responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease. Successful candidate will work 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.
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.
Key Responsibilities Develops new ideas and technologies within an assigned area.May co-ordinate activities of a number of technicians in an assigned phase of a development project.Develops product, test equipment or process improvements and innovations and is responsible for cost improvement programs.Undertakes and successfully completes complex product development tasks including: writing and/or verifying specifications, design verifications and design validations; maintaining product/process documentation; developing test methods.Use of design change process to ensure proposed changes are systematically and thoroughly analyzed before beginning the change process. Whenever product changes are proposed, justification is written or data is collected to verify that the design intent is still met.Designs and coordinates standard engineering tests and experiments.Designs, procures and fabricates tooling and fixtures.Applies Mechanical and Biomedical Engineering knowledge to the design, development and sustaining of prosthetic heart valve systems.Create/develop technical capabilities and expertise related to the design and testing of heart valve technology.Devise strategies for efficient execution of project deliverables and communicates changes in project milestones to key stakeholders and writes project reports as required.Interfaces with Marketing, Operations, Quality Assurance, vendors and possibly physicians. Work collaboratively with manufacturing to reduce product costs through design, prototypes, clinically tests and transfers new product to production and supports these product lines on an ongoing basis.Leads or participates in a cross functional team to perform troubleshooting on products/process problems as related to design, material or process.Promote an innovation mindset, identifies areas for improvement, suggests solutions, and submits patent disclosures.Summarizes, analyzes and draws conclusions from test results and prepares standard reports/documentation to communicate results to technical community.Able to provide technical input within a large team and be an effective communicator within a multidisciplinary and international organisation.Lead and solve complex problems to resolution and solution implementation.Understands and complies with complex regulations, including FDA & ISO, governing the quality systems.Evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers related to materials, manufacturing processes and design.Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects. Demonstrate a primary commitment to patient safety and product quality.Build Quality into all aspects of work by maintaining compliance to all quality requirements.Qualifications Primary or Post-graduate degree in Engineering or related discipline, with 1 to 3 years industrial experience in Structural heart repair or replacement devices and/or delivery system development advantageous. Position requires relevant mechanical/biomedical engineering experience, exposure to design of experiments, specification development, and prototyping.Strong ability to interact and collaborate with a diverse range of colleagues including manufacturing, new product development, preclinical and clinical staff.
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