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.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensuring equipment, tools, fixtures, etc. are up to standards.
• Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.
• Analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Leading and establishing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.
• Collaborating across sites and cross functional teams (R&D and commercial).
• Coordinating manufacturing builds and raw material allocations.
• Leading process validations (IQ, OQ, PQ).
• Supporting documentation for the team.

What you’ll need (Required):

• A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related experience Required.

What else we look for (Preferred):

• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Strong Organizations skills with the ability to manage complex projects/tasks
• Good adaptability in changing projects, directions, and priorities
• Good time management skills to ensure timely completion of tasks
• Ability to drive tasks with minimal supervision; self-starter
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment preferred
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• 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 inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Understanding of Phase-gate product development
• Medical device or regulated industry experience
• Understanding of design requirements documentation, risk management plans, inspection criteria, test method development and validation activities
• Cleanroom environment experience
• Knowledge of manufacturing line design
• Knowledge of process creation and process improvement
• Knowledge of process and design transfer activities
• Understanding/knowledge of Design for Manufacturing (DFM) principles