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Provide technical manufacturing support to Operations and Engineering.

Key Responsibilities:

• Key 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

• Manage all aspects of project management, using such tools as Microsoft Project, Gantt charts, etc., to ensure on-time and on-budget project completion, including interfacing with all parties, allocating resources, negotiating competing priorities, mediating conflicting objectives, and escalating issues as needed for resolution

• Collaborate with Engineering on systemic root cause investigations for CAPA

• 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

• Lead projects to develop new complex tools/equipment for implementation in multiple areas

• Design, develop and sustain processes and procedures, including methods to train users

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

• Provide coaching and guidance to technicians

• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period

• Other incidental duties (e.g. occasional photo copying or deliveries)

Education and Experience:

H.S. Diploma or equivalent 15 Years years experience related experience Required or

Associate's Degree or equivalent 13 Years years experience related experience Required

15 Years years experience previous experience in manufacturing and/or medical device experience Preferred

Additional Skills:

• Excellent written and verbal communication, interpersonal, and relationship building skills with focus on creating presentations, 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 if applicable

• Extensive knowledge of validation and improvement of automated equipment

• Ability to troubleshoot manufacturing equipment

• Knowledge of material compatibility in the proposed use environment

• Ability to execute the fundamentals of project management

• Extensive knowledge of routine preventive maintenance of production equipment

• 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 complex projects, developing work instructions, and providing guidance to advance 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

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.