Senior Specialist, Technical Writing

Full-time - Mid Level

Santa Ana, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

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.

Responsibilities

• 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)
• Provide guidance and training to lower level employees

Requirements

• 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

Nice-to-haves

• Experience in the biotechnology industry (e.g., Quality Assurance, Regulatory)
• Proven expertise in Content Management Systems, topic-based authoring, and authoring using reusable content
• Proficiency in 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

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of our employees and their families