Job Purpose
Design and develop next-generation minimally invasive medical devices for valvular heart disease treatment. Collaborate in a team within a dynamic New Product Development organisation focused on transcatheter heart valve system development for global healthcare markets.
Under limited supervision, compile, analyze, and report data to establish performance standards for new products, processes, and materials.
Key Responsibilities
* Develop new ideas and technologies within assigned areas.
* Coordinate activities of technicians in assigned phases of development projects.
* Develop product, test equipment, or process improvements and innovations, and lead cost improvement programs.
* Complete complex product development tasks, including specification writing, design verification, and validation, as well as maintaining product/process documentation.
* Use the design change process to analyze proposed changes before beginning the change process.
* Design and coordinate standard engineering tests and experiments.
* Design, procure, and fabricate tooling and fixtures.
* Apply Mechanical and Biomedical Engineering knowledge to design, develop, and sustain prosthetic heart valve systems.
* Create technical capabilities and expertise related to heart valve technology design and testing.
* Devise strategies for efficient project execution and communicate changes to key stakeholders.
* Interface with Marketing, Operations, Quality Assurance, vendors, and physicians to work collaboratively and reduce product costs.
* Lead cross-functional teams to troubleshoot products/process problems.
* Promote an innovation mindset and suggest solutions.
* Analyze and draw conclusions from test results and prepare reports to communicate results.
* Provide technical input within large teams and be an effective communicator.
* Lead and solve complex problems to resolution.
* Understand and comply with complex regulations governing quality systems.
* Evaluate, manage, and guide suppliers, including establishing tolerances and defining acceptance criteria.
* Evaluate new equipment/processes/chemicals for environmental impact and demonstrate commitment to patient safety and product quality.
* Build quality into all aspects of work by maintaining compliance to 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.
* Strong ability to interact and collaborate with diverse colleagues, including manufacturing, new product development, preclinical, and clinical staff.