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 Technical Writing position is a unique career opportunity that could be your next step towards an exciting future.
How you'll make an impact:
• Key SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in supporting the widest range of engineering change activities such as product life cycle (PLM) changes (Product Document Creation & Management, Pre-production and Production changes, DHF or Prototype release, Part Author); including developing recommendations for improvement opportunities and proposing technical solutions to optimize processes. End-to-end SME for change control process. Perform complex work using parts, drawings, procedures, written and verbal instructions to perform trouble-shooting functions responsible for change management of CRs and CNs in the PLM system. May create and modify drawings, procedures, process sheets, MES model for fixtures, equipment, products, or processes
• Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback to engineers on procedures and change requests
• Initiate CRs and CNs (Engineering Change Requests and Change Notices)
• Develop understanding for our Manufacturing Execution System (MES) and be able to process changes involving the system
• Other incidental duties (managing the technical writing scrum board, managing office hours for active changes, providing feedback and support to engineering from a PLM standpoint, expedite the change request process, navigate change discussions with multiple functions R&D, RA, MFG, Quality, Operations)
What you'll need (required):
• H.S. Diploma or equivalent and1 year of related experience OR
• Associate's Degree or equivalent
What else we look for (preferred):
• Technical writing or product lifecycle management (documentation management) in regulated industry
• Manufacturing and/or medical device experience
• Good computer skills, including usage of MS Office Suite
• Good written and verbal communication, interpersonal, and relationship building skills
• Ability to troubleshoot PLM system and document changes
• Ability to create presentations, navigate discussions and convey recommendations
• Ability to read, understand, and interpret procedures, drawings, and verbal and written instructions in order to translate them to a coherent and robust change package
• 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.