Edwards Lifesciences Technician, Steerable Catheters in Salt Lake City, Utah
This is a unique opportunity to join the newly created Steerable Catheter Pilot Engineering Group. The Technician will provide technical manufacturing support to Operations and Engineering.
Follow protocols to execute validation, experiments, and tests to develop findings for the validation and improvement of equipment/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 including ECRs, SOPs, drawings, and tooling. Prepare 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)
H.S. Diploma or equivalent with 5 years of previous related experience (clean room, medical device, manufacturing, experience with automated equipment) Required
Knowledge of IQ, OQ, PQ validations Required
Ability to troubleshoot manufacturing equipment Required
Associate's Degree or equivalent Preferred
Excellent computer skills required, including experience with MS Office Suite; ERP/MRP systems experience
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to medical device manufacturing
Knowledge of documentation practices
Strict attention to detail
Ability to provide feedback in a professional, direct, and tactful manner
Ability to work in a team environment and with minimum supervision
Proven success adhering to project schedules and managing small projects
Adhere to all EHS rules and requirements 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.
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.