Job Information
Edwards Lifesciences Senior Principal Engineer, Plant Operations in Irvine, California
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.
How you’ll 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.
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).
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.
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.
Perform other duties and responsibilities as assigned.
What you’ll need (Required):
Bachelor's degree in engineering or scientific with a minimum of 8 years of experience in reliability of facilities, equipment, and/or asset management.
Experience in a regulated manufacturing environment within medical device, biotechnology, pharmaceutical, or related industry.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills.
Expert understanding of related aspects of facilities, utilities, and building systems.
What else we look for (Preferred):
Advanced degree or Certified Maintenance & Reliability Professional (CMRP).
Recognized as a subject matter expert in reliability equipment operations.
Proven leadership experience managing different engineering and professional teams to drive influential change.
Expert understanding of processes and equipment used in assigned work.
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.
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.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.