Manager, Maintenance, Plant Operations… at Edwards… · Irvine

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.