Manufacturing Engineer II

Edwards Lifesciences; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

Edwards Lifesciences in Ireland invites an experienced engineer to join our Manufacturing teams, supporting sewing, assembly, delivery and distribution operations. You will apply Six Sigma/LEAN methods to optimize processes, design experiments, and ensure equipment and tools meet standards.

You will develop training materials, lead project plans, mentor technicians, and collaborate across departments to deliver quality medical devices in a fast-paced environment while adhering to EH&S and

Qualifications

• Bachelor's degree in Engineering or Science with relevant experience.
• Master's degree in Engineering or Science with related experience.
• PhD or equivalent industry experience in Engineering or Science.

Responsibilities

• Optimize manufacturing processes using Edwards systems and Six Sigma/LEAN.
• Develop experiments and tests to qualify processes and analyze results.
• Address CAPA, non-conformances, and audit observations.
• Create work instructions and training materials for production.
• Lead project plans and manage deliverables to meet customer expectations.
• Oversee technicians and coordinate testing activities.
• Support leadership with other assigned duties.

Skills

Six Sigma

LEAN manufacturing

Project management

Documentation

MS Office

Education

Bachelor's degree in Engineering or Science

Master's degree in Engineering or Science

Ph.D. in Engineering or Science

Tools

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 or Equivalent in Engineering or Scientific field, 4 years experience.
• Master's Degree or equivalent in Engineering or Scientific field, 3 years experience.
• Ph.D. or equivalent in Engineering or Scientific field industry experience.

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 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.
• 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.