Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes technical engineering, strategic business planning, process innovation, product compliance, supplier management, or enabling supply chain operations, you will be making a meaningful contribution to our team and to patients all over the world.
Innovation starts from the heart. Heart valve disease impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. At Edwards Lifesciences, our Manufacturing and Engineering teams develop tools, technologies, and processes to power the production of life-changing medical devices to transform patients’ lives.
Within the Tissue Process Engineering Group, this position serves as a technical contributor and workstream lead, supporting the development, integration, deployment, and optimization of advanced tissue manufacturing and laser-based processes for the structural heart valve portfolio.
How you’ll make an impact:
Serve as a technical authority for advanced tissue manufacturing, laser processing, and optical systems integration across the Edwards Implant Network.
Lead technology project workstreams from concept through implementation, including definition of system hardware and software architecture, prototyping and characterization, user requirements/equipment specification definition, vendor selection and management, commissioning, site transfer, and production ramp-up.
Develop and maintain system architecture, interface definitions, alignment tolerances, parameter windows, and subsystem specifications for optics and/or laser-based equipment.
Support the development, evaluation, and integration of complex tissue process technologies and equipment into new product development programs and/or commercial manufacturing and manage lifecycle improvements.
Support the technical project lead overseeing technology development and commercialization, with contributions to project schedules, managing technical risks and mitigation, developing validation and implementation strategies, working in a cross-functional team, and facilitating stakeholder communication throughout design, build, validation, site transfer, and sustainment phases.
Partner closely with the Tissue & Biotechnology Center of Excellence (TABCOE), New Product Development (NPD), New Product Introduction (NPI), Quality, Regulatory, Validation, suppliers, and global manufacturing sites to translate design intent and Voice of the Factory (VoF) into robust tissue manufacturing processes, which includes laser and optical system solutions.
Conduct optimization, and validation of complex equipment or laser-based processes, including authoring and executing characterization studies, IQ/OQ/PQ, and subsequent technical documentation in compliance with regulatory requirements.
Design and execute complex experiments, characterization studies, and develop validation strategies to qualify tissue manufacturing technologies in a highly regulated environment.
Diagnose and troubleshoot equipment issues; identify and document root cause and appropriate corrective action.
Apply principles of optics, optomechanical design, mechanical, electro-mechanical design, automation, vision systems, artificial intelligence, and data analytics to advance tissue manufacturing capability.
Own laser and optical process development activities, including, parameter development, process window characterization, alignment and calibration, process capability studies, and ongoing optimization…