Specialist, Technical Writing - Critical Care_

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world._Appendix:_On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards’ announcement about the acquisition can be found here: dwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bd**How you will make an impact:**• Provide technical writing support for the generation of biological safety assessments based upon Good Laboratory Practices (GLP) protocols and reports, technical summaries, clinical instructions for use (IFUs) and chemical characterization reports for domestic and international regulatory submissions.• Generate and maintain documentation in a standard template format following established guidelines.• Generate formatted tabular data summaries using chemical characterization reports to facilitate the development of toxicological risk assessments. This will include interface with members of the chemistry group to ensure clarity of data presentation.• Support the maintenance of a library of risk summaries to support medical device risk evaluations.• Perform quality control (QC) checks of draft documents to ensure the accuracy of the data and resulting subsequent conclusions.• Support the archiving of completed reports.• Review documents for style, clarity, grammar, and punctuation.• Interface with engineers, regulatory affairs, project teams, lab personnel and management to develop an understanding of the devices.• Ensure compliance with department and company procedures.**What you'll need (Required):**• Bachelors Degree in related field• Minimum of three (3) years’ relative technical writing experience**What else we look for (Preferred):**• Prior experience in the medical device / biotech or regulated industry• Proficient in Good Laboratory Practices (GLP) guidelines, International Standard for Organization (ISO) 10993-1, and quality system requirements for the medical device industry.• Demonstrates professional communication management skills, along with exceptional organization, editing and proofreading skills.• Demonstrated ability to master technical content through interaction with subject matter experts.• Ability to produce documentation that combines creativity with clarity and precision while meeting tight deadlines.• Advanced knowledge and expertise with Windows operating systems and specific documentation tools (MS Word, Excel, PowerPoint, Adobe, etc.)• Thrives in a collaborative team environment - managing and building relationships with internal and external stakeholder groups.Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $65,000 to $92,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.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.