• Job Description

  Req#: Req-42397

  Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Manufacturing Support Technician role is a unique career opportunity that could be your next step towards an exciting future.

  
  How you'll make an impact:
  • 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. Operate a variety of test equipment to assess characteristics of the manufacturing environment
  • Compile documentation for archives to ensure appropriate documentation for development work, including ECRs, SOPs, drawings, and tooling, for Engineering approval
  • Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs. Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.
  • Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
  • Collaborate with Engineering in the development of training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
  • Provide feedback to Engineering on potential opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes.
  • Other incidental duties (e.g. report writing and/or data collection)
  
  What you'll need (required):
  • H.S. Diploma or equivalent

  • 1 year of previous related experience, such as GMP, clean room, medical device, and experience with automated equipment
  
  What else we look for (preferred):

  • Associate's degree or equivalent
  • Excellent computer skills required, including experience with MS Office Suite; ERP/MRP systems experience preferred
  • Ability to read, comprehend, write and speak English, and good communication skills required
  • 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
  • Ability to provide feedback in a professional, direct, and tactful manner
  • Must be able to work in a team environment and with minimum supervision
  • Proven success adhering to project schedules and managing small projects
  • Moderate knowledge of validation and improvement of automated equipment
  • Ability to troubleshoot manufacturing equipment
  • 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.

• About the company

  Edwards Lifesciences is an American medical technology company headquartered in Irvine, CA, specializing in artificial heart valves and hemodynamic monitoring.

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