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USA - California – Irvine, United States of America
Onsite
Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team, part of the AI, Product and Platforms organization, is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It is our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
At Edwards Lifesciences, the IHFM AI, Product and Platforms organization designs and builds the software and data products that clinicians and patients depend on. As a Technical Writer, you own well-scoped controlled documentation that keeps our regulated software traceable and audit ready. You produce and maintain design control artifacts and user-facing documentation with limited guidance, partnering with engineering, quality, and product.
Based in Irvine, CA, you'll join a high-impact medtech innovation hub in the heart of Orange County, collaborating in person with cross-functional teams to shape patient-focused technology.
Create and maintain moderately complex Good Manufacturing Practices (GMP) protocols, reports, technical summaries, and test procedures.
Develop well-scoped controlled documentation that supports regulated software traceability and audit readiness.
Maintain documentation in a standard format and follow established guidelines for content quality, organization, and consistency.
Partner with production employees, technicians, engineers, project teams, regulatory partners, and management to understand product, component, or device changes.
Review documents for style, clarity, grammar, punctuation, and overall usability.
Identify and resolve inconsistencies in content, structure, or document development, and work with authors to recommend appropriate updates.
Respond to requests for clarification or explanation of reference materials and technical documentation.
Support additional documentation-related needs as assigned by leadership.
Bachelor’s degree in a related field and 3 years of technical writing experience, or equivalent work experience based on Edwards criteria.
Relocation is not provided for this role. Only candidates within a 50-mile radius of Irvine, California will be considered.
Biotechnology, medical device, or regulated industry experience, or equivalent work experience based on Edwards criteria.
Experience creating or maintaining documentation types such as procedures, routers, process sheets, technical summaries, protocols, and test reports.
Solid understanding of policies, procedures, and guidelines relevant to technical documentation development.
Strong editing, proofreading, and technical writing skills, with careful attention to style, clarity, grammar, and punctuation.
Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Publisher; Adobe and Photoshop experience preferred.
Good written and verbal communication skills in English, with strong interpersonal skills.
Good problem-solving, critical thinking, organization, and prioritization skills in a fast-paced environment.
Ability to work independently on more complex projects or lines of work, with work reviewed for accuracy and soundness.
Ability to collaborate across interdepartmental teams, build productive internal and external working relationships, and represent the organization on specific projects.
Strict attention to detail and commitment to following all company rules and requirements, including Environmental Health & Safety expectations and applicable protocols.
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 (CA), the base pay range for this position is $68,000 to $96,000 (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.