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.
Applies skill in the preventive and unexpected in-process maintenance of production equipment for commercial products and equipment used in pre-commercial products to ensure ongoing optimum performance, in compliance with EHS, Good Manufacturing and Good Documentation Practices, and other applicable quality and regulatory guidelines associated with medical device manufacturing.
The standard hours for this role are Sunday-Thursday 9:30pm-6:00am with potential for overtime.
How you'll make an impact:
• Performing both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and to avoid program down time
• Checking for failures in more complex in equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing an impact assessment reports of incidents
• Troubleshooting and recommending maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance
• Applying knowledge of processes in the use of machines to ensure successful outcomes, as well as to devise complex process changes
• Reviewing, following and performing check list actions for all equipment in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and entering information into CMMS (Computerized Maintenance Management System)
• Collaborating with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs)
• Providing training, coaching, guidance, and information as requested and needed
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other incidental duties: General work area housekeeping, cross-functional team meetings, maintaining certification in required areas of operation
What you'll need (Required):
H.S. Diploma or equivalent 8 years experience related experience; working knowledge of electrical, mechanical, lubrication, pneumatic, boiler, autoclave, and/or HVAC system operations Required and
in completed trade school program in electric, mechanical, and/or electronics, including internship Required
What else we look for (Preferred):
• Full knowledge of routine preventive maintenance of production equipment
• External training in system troubleshooting (e.g., electrical, mechanical, and/or electronics)
• Good communication skills
• Ability to provide feedback in a professional, direct, and tactful manner
• Able to read, comprehend, speak, and write English
• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to the manufacturing floor operations and clean room medical device manufacturing
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work with minimum supervision by following detailed maintenance instructions, and provide guidance and training to lower-level technicians
• Work in an inter-departmental team environment, as well as with colleagues from other departments, and represent the organization to outside contacts, e.g., contractors, vendors, suppliers
• Good computer skills, including MS Office
• 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
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 $58,000 to $82,000 (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 protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.