Job Abstract

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 Engineer, Plant Operations 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 understanding of related aspects of facilities, utilities, and building systems.
• Expert understanding of architectural designs, building codes, construction/project management principles.
• Advanced problem-solving, organizational, analytical and critical thinking skills.         
• Expert understanding of processes and equipment used in assigned work.
• Strong leadership skills and ability to influence change.

What else we look for:

• Advanced degree or Certified Maintenance & Reliability Professional (CMRP). 
• Proven expertise in usage of MS Office Suite; CAD, REVIT & Solidworks experience
• Experience in FDA and cGMP regulations and documentation practices.
• Proven expertise in usage of MS Office Suite; CAD experience preferred.
• Recognized as a subject matter expert in reliability equipment operations.
• Expert understanding of processes and equipment used in assigned work.
• Proven leadership experience managing different engineering and professional support teams salary, hourly and contractor.
• 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.
• Advanced problem-solving, organizational, analytical, and critical thinking skills.
• Strong leadership skills and ability to influence change.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Interacts with senior external representatives on significant technical matters often requiring coordination between organizations.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $133,000 to $187,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.