Sr Engineer, Manufacturing

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. Documentation creation for process transfer from sending to receiving site (Part numbers, BOM, router, MES models, process documentation).
2. Identify and ensure 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 ensure equipment, tools, fixtures, etc. are up to standards.
3. Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
4. Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
5. Lead and 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:

Bachelor's Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education Required or Master’s Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education Required or Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required.

What else we look for:

1. Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
2. Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
3. Basic understanding of statistical techniques.
4. Previous experience working with lab/industrial equipment required (if applicable).
5. Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
6. Strong problem-solving, organizational, analytical and critical thinking skills.
7. Substantial understanding of processes and equipment used in assigned work.
8. Good leadership skills and ability to influence change.
9. Knowledge of applicable FDA regulations for medical device industry.
10. Strict attention to detail.
11. Ability to interact professionally with all organizational levels.
12. Ability to manage competing priorities in a fast-paced environment.
13. Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
14. 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.