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 t…
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$68k–$96k/yr
Full-time
bachelor degree
Performance-based Incentives, Competitive Salaries, Diverse Benefits Programs
Posted 40d ago
~40 hrs/week
Responsibilities
Create and maintain moderately complex GMP protocols, reports, and technical summaries for heart failure management technology. Collaborate with cross-functional stakeholders to document product changes and ensure clarity and consistency across all technical materials.
Requirements
Requires a Bachelor's degree in a related field and 3 years of technical writing experience. Preference is given to candidates with medical device or biotechnology industry experience and proficiency in specialized documentation software.
Full job description
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.
How You’ll Make an Impact
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.
What you'll need (Required):
Bachelor’s degree in a related field and 3 years of technical writing experience, or equivalent work experience based on Edwards criteria.
This is an onsite role based in Irvine, CA. Relocation assistance is not provided, and candidates must reside within a 50-mile radius of Irvine to be considered.
What else we look for (Preferred):
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.
Global leader in the medical device industry with a patient-focused culture of innovation
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1958
Headquarters
Irvine, CA
LinkedIn followers
429,899
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Contact Us
We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus
If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm.
All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
Medical DevicesHeart ValvesSurgical MonitoringStructural Heart DiseaseHealth Care TechnologyHeart InnovationsMedical InnovationsHeart Valve TechnologiesHeart Valve TherapiesTranscatheter Mitral &Tricuspid Therapies
How many Healthcare jobs are open in Irvine, CA right now?
There are currently 1,134 open healthcare positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Irvine, CA?
Companies currently hiring include UCI Health, Edwards Lifesciences, City of Hope, Allergan, Hoag Health System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Irvine, CA?
Yes — 201 of the 1134 open healthcare positions offer remote or hybrid work (69 remote, 132 hybrid).
How do I apply for Healthcare jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.