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.

This Senior Engineer will join our Implant Network to optimize and improve our manufacturing processes, develop and execute complex experiments, lead and execute project plans, and manage business continuity projects.

How you will make an impact:

· Identifying and ensuring 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.

· Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.

· Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

· Leading, establishing, and executing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).

· Supporting cross-functional projects with VSIE, VIP, Tiger Team, LCM, Commercialization, and Ops Manufacturing across all business units.

· Acting as a technical product and process subject matter expert for global manufacturing sites. Aligning manufacturing sites and business unit objectives, programs, and resources.

· Completing business continuity projects and aligning product changes and launches with IIM planning. Executing complex projects by understanding technical challenges, implementation, costs, regulatory risks, and developing recommendations for strategic decision making.

What you’ll need (Required):

· Bachelor's Degree in Engineering or Scientific field with 4 years of previously related experience OR Master’s Degree in Engineering or Scientific field with 3 years of previously related experience Required.  

What else we look for (Preferred):

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

· Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

· Strong understanding of statistical techniques

· Previous experience working with lab/industrial equipment preferred

· Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering

· Strong problem-solving, organizational, analytical and critical thinking skills

· Proven success in project management leadership

· 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

· Technical knowledge in manufacturing engineering of medical devices, including process excellence methodologies such as Six Sigma, cGMP, DFM, LEAN, FDA guidelines, ISO standards, ergonomics, GD&T, automation and equipment design, and implementation.

· 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

· <