Provide technical manufacturing support to Operations and Engineering.

Key Responsibilities:

• Perform weekly preventive maintenance routines for equipment to avoid program down time

• 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

• Execute experiments and tests (following 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

• 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

• Identify potential improvement opportunities and propose solutions to optimize equipment, e.g., re-design/design of basic equipment, tools, fixtures, for Engineering review

• Troubleshoot basic manufacturing equipment

• May lead small projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework

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

• Provide coaching and guidance to technicians

• Other incidental duties

Education and Experience:

H.S. Diploma or equivalent 4 years years experience related experience Required or

Associate's Degree or equivalent 2 Years years experience related experience Required

Previous experience in manufacturing and/or medical device experience Preferred

Six Sigma Yellow Belt Certification Preferred

Additional Skills:

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

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

• Good computer skills, including usage of MS Office Suite

• Moderate knowledge of validation and improvement of automated equipment

• Ability to troubleshoot manufacturing equipment

• Basic knowledge of material compatibility in the proposed use environment

• Moderate knowledge of routine preventive maintenance of production equipment

• Moderate 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 under limited supervision

• 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

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.