Senior Principal Facilities Engineer

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.The Sr. Principal Facilities Engineer will execute projects and support sustaining operations including some of the following engineering disciplines: architectural, mechanical, electrical, and civil. This role will also drive energy optimization, building code analysis, project scheduling, estimating, and construction management. This position will work on all new implementations for new manufacturing spaces within the Irvine campus, including FDA regulatory submission readiness.The Sr. Principal Facilities Engineer is a key technical leadership role requiring sound technical insight to be deployed both strategically and tactically to support manufacturing operations 24/7/365. This position will require weekend, holiday, and plant shutdown support during non-manufacturing and off hours/schedules as needed.Key Responsibilities:

Sustaining manufacturing support of operations and maintenance through critical systems and environmental controls

Drive and implement asset lifecycle management strategies for Critical GMP facilities equipment

Drive the development and manage the execution of highly complex 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

Support controlled environment qualifications, IQ/OQ/PQ executions, including regulatory submissions support to regulatory bodies per ISO 14644-1,2

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

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

Train, coach, and guide lower level employees on highly complex procedures

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 equipment repair tasks; give instruction to technicians/technologists on conducting repair or maintenance; train technicians and provide feedback; and coordinate technician work

Minimum Qualifications:

Bachelor’s Degree in Engineering or Scientific field with 8 years of experience required OR

Master’s Degree in Engineering or Scientific field with 7 years of experience required OR

Ph.D. in Engineering or Scientific field with 4 years of experience required

Preferred Qualifications:

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

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

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

Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Represents organization as key technical contact on contracts and projects

Interacts with senior external representatives on significant technical matters often requiring coordination between organizations

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Knowledge of applicable FDA regulations for medical device industry

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 $123,000 to $174,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.