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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.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. 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:
Optimizing manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.
Developing moderately 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 moderately 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.
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):
What else we look for (Preferred):
Good computer skills in usage of MS Office Suite including MS Project
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Strong organization 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
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 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 the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.