Technical Writer

Posted 3 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
68K-96K Annually
Mid level
Healthtech • Pharmaceutical
The Role
Create and maintain GMP protocols, technical summaries, test procedures, and other documentation. Collaborate with production, engineering, regulatory, and management to capture device changes. Edit for style, clarity, and consistency, recommend improvements, respond to documentation queries, and perform other duties as assigned.
Summary Generated by Built In

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) business’s 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.

How You’ll Make an Impact
  • Provide technical writing expertise to create moderately complex Good Manufacturing Practices (GMP) protocols and reports, technical summaries, and test procedures.

  • Maintain documentation in a standard format following established guidelines.

  • Collaborate with stakeholders, including production employees, technicians, engineers, project teams, regulatory teams, and management, to understand product, component, or device changes.

  • Review documents for style, clarity, grammar, and punctuation.

  • Identify and correct inconsistencies in content, development, or organization, and partner with authors to recommend appropriate adjustments to documents and procedures.

  • Respond to requests for clarification or explanation of reference materials and technical documentation.

  • Perform other duties as assigned by leadership.

What You’ll Need
  • 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.

What Else We Look For
  • Biotechnology, medical device, or healthcare industry experience

  • Expertise in technical documentation software administration like MedCap Flare, Adobe, Paligo

  • Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Publisher; Adobe and Photoshop experience preferred.

  • Strong editing, proofreading, and technical writing skills.

  • Good written and verbal communication skills in English, with strong interpersonal skills.

  • Good problem-solving and critical thinking skills.

  • Solid knowledge and understanding of policies, procedures, and guidelines relevant to technical documentation development.

  • Solid knowledge of documentation types, such as procedures, routers, process sheets, technical summaries, protocols, and test reports.

  • Solid knowledge of product assembly procedures.

  • Ability to work independently on more complex projects and/or lines of work, with work reviewed for accuracy and soundness.

  • Ability to manage competing priorities in a fast-paced environment.

  • Strict attention to detail.

  • Ability to work in a team environment, including interdepartmental teams, and represent the organization on specific projects.

  • Ability to build productive internal and external working relationships.

  • Commitment to following all company rules and requirements, including pandemic protocols and Environmental Health & Safety rules, and taking appropriate control measures to help prevent injuries, protect the environment, and prevent pollution within the area 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 (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.

Skills Required

  • Bachelor's degree in a related field
  • 3 years of technical writing experience or equivalent work experience per Edwards criteria
  • Must be located within a 50-mile radius of Irvine, California; relocation not provided
  • Experience in biotechnology, medical device, or healthcare industry
  • Expertise with technical documentation software administration (MedCap Flare, Adobe, Paligo)
  • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Publisher); Adobe and Photoshop experience preferred
  • Strong editing, proofreading, and technical writing skills
  • Knowledge of GMP documentation types: procedures, routers, process sheets, technical summaries, protocols, and test reports
  • Knowledge of product assembly procedures
  • Ability to work independently on complex projects with accuracy and manage competing priorities
  • Strong written and verbal communication, interpersonal, problem-solving, and critical thinking skills

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Retirement Support Retirement programs include a 401(k) match complemented by a separate profit‑sharing contribution. These elements add meaningful long‑term value to total compensation.
  • Equity Value & Accessibility An employee stock purchase plan with a discount and look‑back feature, alongside stock awards for eligible roles, provides notable upside. Program expansions indicate continued accessibility.
  • Leave & Time Off Breadth Time‑off policies include generous PTO, company holidays, and a year‑end holiday shutdown. These offerings enhance work‑life support when available at the site.

Edwards Lifesciences Insights

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The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. 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. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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