Manager, Maintenance, Plant Operations Engineering

Edwards Lifesciences • Irvine, CA • 20min ago

USA - California - Irvine

Full time

Req-51912

Schedule: Tuesday to Saturday, 7:30 a.m.-4:30 p.m.

Imagine how your ideas and expertise can change a patient's life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

The Manager will provide strategic and operational leadership for plant maintenance, facilities, and engineering in a GMP-regulated manufacturing environment. Ensure equipment reliability, facility performance, safety, regulatory compliance, operational excellence, and cost-effective project execution.

How you'll make an impact:

Lead maintenance and facilities teams, manage staffing, establish priorities, and develop technical capabilities.

Oversee preventive, predictive, corrective, and emergency maintenance to minimize downtime and improve equipment performance.

Ensure GMP, SOP, GDP, and regulatory compliance, including deviations, CAPAs, and change controls.

Manage capital projects, facility improvements, equipment upgrades, commissioning, and qualification.

Maintain accurate records, work orders, risk assessments, and equipment history through CMMS (preferably Maximo).

Partner with cross-functional teams and contractors while enforcing EHS, LOTO, JSA, and risk management requirements.

Monitor KPIs, optimize resources, and manage operating and capital budgets.

What you'll need (Required):

Bachelor's degree in Engineering or a related technical field, or equivalent experience.

Minimum 5 years of relevant maintenance, facilities, or engineering experience, including 2 years in leadership.

Experience in regulated manufacturing, preferably medical devices or pharmaceuticals.

Strong technical problem-solving, team leadership, and cross-functional collaboration skills.

Onsite required to support manufacturing operations.

Availability to support critical operations and off-hours emergencies which may include weekends.

What else we look for (Preferred):

Experience with GMP facilities, cleanrooms, critical utilities, laboratories, and production equipment.

Proficiency in Maximo.

Experience managing capital projects, contractors, commissioning, qualifications, and budgets.

Knowledge of GMP, 21 CFR Parts 210/211, applicable medical-device regulations, ICH Q9/Q10, and inspection readiness.

Proficiency in ALCOA principles, data integrity, CAPA, change control, investigations, and risk assessments.

Understanding of DQ/IQ/OQ/PQ, equipment qualification, and acceptance criteria.

Knowledge of HVAC, cleanrooms, environmental controls, purified water/WFI, compressed gases, electrical systems, and building automation.

Experience with CMMS, BMS/EMS/SCADA, calibration, electronic quality systems, and applicable 21 CFR Part 11 requirements.

Application of FMEA, asset criticality, predictive maintenance, PM optimization, spare-parts management, MTBF, and MTTR.

Knowledge of contamination control, contractor safety, audits, budgets, contracts, and capital expenditures.

Demonstrates technical expertise, accountability, effective communication, and sound decision-making.

Develops employees, manages competing priorities, and promotes a culture of safety, quality, compliance, teamwork, and continuous improvement.

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

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Similar Jobs

Banquet Bartender (Temporary)

Hilton • Downey, CA • 5h ago

Retail & Hospitality

Job Identification: 231161 Job Category: Food and Beverage Job Schedule: Part time Salary 18.00 Equal Opportunity Employer EOE, including disability/vets Exceptional Hospitality Starts with You Picture yourself brighteni...

5h ago

Go to Apply

Banquet Server (Temporary)

Hilton • Downey, CA • 5h ago

Retail & Hospitality

Job Identification: 231156 Job Category: Banquets Job Schedule: Part time Salary 18.00 Equal Opportunity Employer EOE, including disability/vets Exceptional Hospitality Starts with You Picture yourself brightening someon...

5h ago

Go to Apply

Housekeeping Coordinator ($29.50/hour)

Hyatt • Irvine, CA • 5h ago

Retail & Hospitality

Description: The Housekeeping Coordinator assists with all office duties of the housekeeping department such as payroll, ordering, etc. This position has a high level of guest phone contact. This person must demonstrate...

5h ago

Go to Apply

Site Supervisor Beach Front Hotel

Allied Universal • Newport Beach, CA • 5h ago

Retail & Hospitality

Company Overview: Allied Universal®, North America's leading security and facility services company, offers rewarding careers that provide you a sense of purpose. While working in a dynamic, welcoming, and collaborative...

5h ago

Go to Apply

Niagara Bottling LLC • Diamond Bar, CA • 1d ago

Retail & Hospitality

Corp-Main - Diamond Bar, CA Full time R57270 Join Niagara Bottling, a leading beverage manufacturer built on the mission of providing high-quality affordable beverages since 1963. Through innovation, collaboration, and a...

1d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)