Job Description

**Job Description:** 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 Sr. Specialist, Technical Writer position is a unique career opportunity that could be your next step towards an exciting future. The Sr. Specialist, Technical Writing role will develop and create accurate Good Manufacturing Practices (GMP) technical documents. **How you'll make an impact:** - Provide technical writing expertise to create complex design control documentation packages including process validation documents (e.g, Installation Qualification, Operations Qualification, Process Qualification) Good Manufacturing Practices (GMP) protocols and reports, technical summaries, and test procedures - Collaborate with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes - Maintain documentation in a standard format following established guidelines - Review documents for style, clarity, grammar, and punctuation - Identify and correct inconsistencies of thought, development, or organization and confer with authors to recommend an appropriate adjustment in documents and procedures - Recommend improvements to current documentation practices and propose recommended changes - May lead special projects (e.g implementation of new style of documentation procedures) - Other duties assigned by Leadership; Provide guidance and training to lower level employees **What you'll need (Required):** - Bachelor's Degree in related field and 5 years of technical writing experience **OR** - Master's Degree in a related field and 3 years of technical writing experience **What else we look for (Preferred):** - biotechnology industry (e.g., Quality Assurance, Regulatory) - Proven expertise in Content Management Systems, topic-based authoring, and authoring using reusable content. Microsoft Office Suite including Word, Excel, PowerPoint, and Publisher; Adobe InDesign and Photoshop preferred. Experience with RWS Tridion Docs preferred - Excellent editing and proofreading skills - Excellent written and verbal communication skills in English including negotiating and relationship management skills - Excellent problem-solving and critical thinking skills - Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation - Full knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports) - Excellent technical writing skills - Full knowledge of product assembly procedures - Ability to manage competing priorities in a fast paced environment - Strict attention to detail - Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects - Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations - 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 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 $80,000 to $113,000 (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.

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