Manufacturing Engineer II, Transfer Engineering

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. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How youll make an impact:

• 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

• Develop moderately 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 moderately 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

• Establish project plans to ensure deliverables are completed to customers 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 youll need (Required):

• Bachelors Degree in an Engineering or Scientific field with at least 2 years of related work experience OR

• Masters Degree or equivalent with internship senior projects or thesis in an Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred):

• Hands on manufacturing and/or equipment experience

• Experience with process validations

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience

• Good 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

• 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

• 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