Senior Engineer, Manufacturing

Edwards Lifesciences; Moncada; On-site; EUR 42,000 - 66,000; Full time

Job summary

Edwards Lifesciences in Spain seeks a Manufacturing Engineer to optimize processes across sewing, assembly, delivery, and distribution. You will apply engineering principles and lean methods to drive improvements and ensure equipment and fixtures meet standards.

You will develop experiments, analyze results, train technicians, manage projects, and support compliance with FDA-regulated medical device standards.

Qualifications

• Bachelor's degree in Engineering or a related scientific field.
• Master's degree or PhD is preferred depending on experience.
• Fluent in English and Spanish required.

Responsibilities

• Optimize manufacturing processes using Six Sigma/LEAN methods.
• Identify opportunities to improve processes and ensure equipment meets standards.
• Develop experiments and tests to qualify and validate processes.
• Analyze and resolve manufacturing and compliance issues.
• Develop training and work instructions for production.
• Lead project plans and manage deliverables.
• Oversee manufacturing support tasks and coordinate technicians.
• Perform other duties assigned by leadership.

Skills

Attention to detail

Fluent English

Fluent Spanish

Project management

Problem-solving

Education

Bachelor's degree in Engineering or scientific field

Master's degree or equivalent

Ph.D. in Engineering or scientific field

Tools

MS Office

MS Project

CAD

Job description

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.

How You Will Make an Impact:

• Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
• 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
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• 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.)
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership

What You Will Need (Required):

• Bachelor's Degree in Engineering or Scientific field with, 4 years experience
• Master's Degree or equivalent in Engineering or Scientific field with, 3 years experience
• Ph.D. or equivalent in Engineering or Scientific field with industry experience
• Fluent English & Spanish

What Else We Look For (Preferred):

• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• 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 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
• 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

Please submit your application in English.