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Manufacturing engineer ii

Edwards Lifesciences
Publicada el 1 agosto
Descripción

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

We recently announced plans to expand in Spain by building a new, state-of-the-art manufacturing plant in Moncada, Valencia. When it becomes operational in 2026, the plant will manufacture Edwards' surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 dedicated team members by 2029 across manufacturing, engineering, and several other professional career paths. Hiring for professional positions has started and will continue through the winter and early spring, with specialized training for manufacturing hires beginning in the fall of 2025.

The Role:

Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

How you will make an Impact:

1. Optimize 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
2. Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
3. Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
4. Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
5. Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
6. Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
7. Other incidental duties assigned by Leadership

What you will need:

1. Bachelor's Degree in Engineering or Scientific field, with a minimum of 2 years of relevant experience
2. Master's Degree or equivalent internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education experience

What else we look for:

* Good computer skills in MS Office Suite including MS Project; CAD experience preferred (if applicable)
* Good documentation, communication (written and verbal), and interpersonal skills including consultative and relationship management skills
* Basic understanding of statistical techniques
* Previous experience working with lab/industrial equipment required (if applicable)
* Solid understanding of principles, theories, and concepts relevant to Engineering
* Strong problem-solving, organizational, analytical, and critical thinking skills
* Knowledge of processes and equipment used in assigned work
* Knowledge of Edwards Environmental Health and Safety and Quality guidelines related to clean room medical device manufacturing
* Understanding of applicable FDA regulations for the medical device industry
* Strict attention to detail
* Professional interaction skills across organizational levels
* Ability to manage competing priorities in a fast-paced environment
* Teamwork skills, including managing vendors and project stakeholders
* Ability to build productive internal/external relationships
* Adherence to company rules and safety protocols, including pandemic measures, and environmental safety standards
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