2nd Shift Senior Engineer, Manufacturing

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.

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

** How you'll make an impact:*
* + 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'll need (Required):*
* + Bachelor's Degree in Engineering or Scientific field with 4 years of experience including either industry or industry/education OR

+ Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience including either industry or industry/education OR

+ Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

** What else we look for (Preferred):*
* + Experience working in the medical device industry

+ Experience managing a variety of different product lines

+ Proven expertise in usage of MS Office Suite including MS Project; CAD experience

+ 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

+ 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 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…