Senior Principal Engineer, Reliability

Joining Edwards Lifesciences means innovating, pushing boundaries, and being creative while always putting patients first. It means solving challenges with colleagues who share your sense of urgency, optimism, and enthusiasm, colleagues who are just as focused on testing their limits and taking ownership. And it means that you will be empowered to get the job done by taking charge of your work and your career.  Innovation is at the core of Edwards! Without it, we would not be able to produce the life-saving products and therapies that transform lives around the world. That is why we surround ourselves with people who are not afraid to question the status quo or express a different point of view.

Edwards Lifesciences is hiring a Sr. Principal Reliability Engineer who will provide expertise in the optimization of manufacturing equipment processes. This is a unique opportunity to be part of our high performing production Irvine Implant Plant operations in a corporate environment.

How you will make an impact:

• Drive the development and manage the execution of highly complex equipment experiments and tests (including writing and executing protocols) on a platform which includes multiple product lines to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion.
• Initiate and lead the identification 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 on new products and/or processes, etc. are up to standards.
• Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• 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.
• May be selected as an Independent Reviewer for design review.
• May support and lead Business Excellence activities through tier meetings and support business continuity implementation such us Total Productive Maintenance (TPM).
• Subject matter expert for life cycle reliability on new equipment development and acquisition for critical systems . i.e. RODI & CDA
• Perform other duties and responsibilities as assigned.
• Initiate and lead the identification of programs and solutions for increasing uptime and for utility problems that affect the manufacturing process to optimize/improve including using engineering methods.
• Responsible for work safely and environmental regulations by observing and enforcing safety rules, policies, and procedures.
• Drive the development and manage the execution of the equipment preventative maintenance schedules, make recommendations, and develop reports and collaborate with team members to drive project completion.
• Analyze and resolve complex facilities and utilities issues with highest complexity (e.g., CAPA, non-conformances, audit observations).
• Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• May be selected as an Independent Reviewer for design review.
• Support internal and external quality audits in front/backroom as required.
• Perform other duties and responsibilities as assigned.

What you’ll need:

• Experience in a regulated manufacturing environment within medical device, biotechnology, pharmaceutical, or related industry.
• Bachelor's Degree + minimum of 8 years OR Master's Degree + minimum of 7 years OR Doctorate in Engineering or Scientific field + minimum of 4 years of experience, including either industry or industry/education.
• Experience in reliability of facilities, equipment, and/or asset management required on a 24/7 team environment.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills.
• Ability to translate complex and technical information to all levels of the organizations.
• Recognized as an expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines.
• Expert understanding of safety regulations as dictated by local regulating bodies (e.g., US OSHA, US NFPA).
• Expert knowledge and understanding of principles, theories, and concepts relevant to Engineering.
• Expert u