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.

2nd Shift Hours are: Monday to Thursday from 3:30 p.m. to 2:00 a.m.

How you will make an impact:

• Troubleshooting and recommending maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance.

• Leading projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework.

• Performing both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time.

• Checking for failures in more complex equipment and processes, and performing corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents.

• Collaborating with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).

• Reviewing documentation and taking 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.

• Utilizing manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems.

• Collaborating with Engineering and CAD/Designers to develop new basic tools

• Providing coaching and guidance to technicians.

• On time arrival to work with regular attendance without excessive absenteeism.

What you’ll need (Required):

• High School Diploma with 6 years of prior related experience OR Associate’s Degree with 4 years of prior related experience Required.

What else we look for (Preferred):

• Previous experience in manufacturing and/or medical device experience preferred

• Strong written and verbal communication, interpersonal, and relationship building skills

• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)

• Strong computer skills, including usage of MS Office Suite; and CAD if applicable

• Full knowledge of validation and improvement of automated equipment

• Ability to troubleshoot manufacturing equipment

• Knowledge of material compatibility in the proposed use environment

• Ability to understand the fundamentals of project management

• Full knowledge of routine preventive maintenance of production equipment

• Full 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

• Strict attention to detail

• Must be able to work with other departments including formulating work instructions and providing guidance and training to lower-level employees with little to no direction

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.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.