Manager, Maintenance, Plant Operations Engineering USA - California – Irvine Full time Req-51912

Job description

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. SHARE THIS JOB Job reference Req-51912 Apply Now Type Full time Category Engineering Location USA - California – Irvine Posted for 14 hours ago SHARE THIS JOB Apply Now About Edwards Lifesciences 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. ‌ What we offer Diversity, inclusion & belonging Find out more Our benefits Find out more Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds. Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.