Irvine, CA, 92604, USA
22 hours ago
Senior Maintenance Technologist, Extrusions
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. Join our dynamic and rapidly growing area of extrusions as a Senior Maintenance Technologist. We are searching for a seasoned professional with industry experience who is ready to dive deep into the intricacies of equipment, tooling, and extrusion process development. **How you'll make an impact:** + SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in asset management, equipment maintenance, and manufacturing support activities + Design, set-up and execute complex feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review + Lead and manage projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework + Collaborate with Engineering on product/process root cause investigations + Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval + Utilize manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems (e.g., ECRs, Blue Mountain) + Collaborate with Engineering and CAD/Designers to develop new complex tools/equipment + Source new equipment for implementation into PEG, Pilot, and manufacturing + Provide coaching and guidance to technicians + Perform primarily unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time, including providing expertise and guidance in resolving complex failures + Check for failures in equipment and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs) + Troubleshoot, as well as anticipate issues, and propose solutions to limit downtime and keep production on schedule + Apply in-depth knowledge of processes in the use of machines to ensure successful outcomes, devise complex process changes, and ensure knowledge transfer to other levels of technicians + Operate a variety of test equipment to assess characteristics of the manufacturing environment + Other incidental duties **What you'll need (Required):** + High School Diploma or equivalent with 10 years of related experience OR + Associate's Degree or equivalent with 8 years of related experience + Experience in manufacturing **What else we look for (Preferred):** + Experience with extrusion + Certifications in machining, electrical, electrical safety, and/or SolidWorks + Ability to troubleshoot manufacturing equipment + Extensive knowledge of routine preventive maintenance of production equipment + Extensive knowledge of validation and improvement of automated equipment + Excellent written and verbal communication, interpersonal, and relationship building skills with focus on influencing and conveying recommendations + Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices) + Strong computer skills, including usage of MS Office Suite; and CAD + Knowledge of material compatibility in the proposed use environment + Ability to understand the fundamentals of project management + Extensive knowledge electrical, mechanical, electronic, pneumatic, and controls + Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment + Must be able to work independently in completing assigned projects, developing work instructions, and advancing the competency of other technicians + 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 (CA), the base pay range for this position is $68,000 to $97,000 (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.
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