Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. The Role The Quality Engineer II applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. How Will You Make An Impact? Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports Optimize manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work What You Will Need? A Bachelor's degree in Engineering or a Scientific field Minimum of 2 years' experience in Quality or Manufacturing is required What Else We Require? Good computer skills in usage of MS Office Suite; CAD experience preferred Good documentation, communication and interpersonal relationship skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment required Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering Solid problem-solving, organizational, analytical and critical thinking skills Solid understanding of processes and equipment used in assigned work Knowledge of and adherence to Quality systems Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including the ability to manage vendors and project stakeholders Ability to build stable working relationships internally Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer position is a unique career opportunity that could be your next step towards an exciting future. How you will make an Impact: Provides technical leadership in the design and development of complex automated equipment and assemblies, with strong understanding of mechanical and automated systems design validation and integration. Have detailed knowledge of Design platforms including 3D CAD (e.g., SolidWorks, Creo, Inventor) and simulation packages. Ability to produce detailed engineering drawings, BOMs, and URS documentation to Medical Device standards. Develop design calculations, simulations, and engineering analyses (e.g., FEA, tolerance stack-ups), FMEA and machine safety CMSE experience Evaluate design concepts for feasibility, manufacturability, cost, and performance. Perform stress analysis, material selection, fluid/thermal calculations including CFD, and reliability assessments. Review and approve vendor equipment designs and proposals. Conduct design reviews, DFMEA, and risk assessments. Ensure designs meet internal standards, industry codes, and regulatory requirements (ISO, ASME, PED, etc.). By driving cross functional alignment between multiple functions within the business and ensuring robust, compliant and efficient manufacturing process. Establish strategic and detailed plans to tackle diverse and complex tasks, such as testing issues and machine issues which require analysis, data, and in-depth evaluations. These tasks support the design, prototyping, assembly, and development of improvements and/or automation of existing processes and mechanical components. Lead and drive the development and manage the execution of complex projects or experiments. Lead collaboration with cross-functional partners to conduct complex technical experiments, research, and design various prototypes to achieve consensus and make informed technical decisions. Lead improvement activities within internal or external teams, or manufacturing processes to drive enhancements and improve efficiency. Utilize metrics to perform continuous improvement. Train, coach, and guide junior/senior engineer on complex technical task. Review works and may direct others to supervise. Lead the development and influence multiple development teams and various technical domains to support and drive improvements and changes. Establish and enforce engineering standard, best practices, and methodologies to ensure efficiency and quality engineering results. What you will need (Required): Bachelor's Degree in Engineering or Scientific field , 4 years experience working in automation domain What else we look for (Preferred): Whichever applicable, expert skills (with years of proven record) in mechanical design, or programming skills (PLC, Robotics, or vision), or electrical design Demonstrates proficiency in creating excellent technical documentation, white papers, and technical write-ups Ability to translate technical information to all levels of the organisation Capable of delivering effective presentations on complex technical information and project activities Knowledge of applicable FDA regulations for medical device industry is a plus Substantial understanding of processes and equipment used in assigned work Extensive knowledge and understanding of principles, statistic, theories, and concepts relevant to Engineering Advanced problem-solving, organizational, analytical and critical thinking skills with proven record Strict attention to detail Ability to manage competing priorities in a fast paced environment, including the ability to manage vendors and project stakeholders Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills Must be able to work in a team environment, including frequent inter-organisational and outside customer contacts Represents organisation in providing solutions to difficult technical issues associated with specific projects Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Ability to interact professionally with all organisational levels Demonstrates strong technical leadership, influences multiple development teams and various technical domains, supports and drives company improvements and changes. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
