Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solution is seeking an Instrument Documentation Writer in San Diego, CA. This role will be reporting to the Manager, Verification and Validation. This position will provide technical writing support for instrument and software operator manuals, technical bulletins, specifications, and training materials. As a member of the R&D Instruments group, this position will take in technical information from multiple cross-functional groups to develop instrumentation manuals (operators manuals, service manuals), field technical bulletins, and training materials.

To be successful in this role, we are seeking individuals who have at least a Bachelor’s degree, preferably in English or Technical Communication, similar related fields. Plus, a minimum of five years of experience writing end-user software or hardware instructions. Experience in the medical device industry and working in a federally regulated environment (FDA/UMDR) are preferred.

Primary responsibilities for role:

• Revise and edit legacy product documentation as required, including but not limited to user’s guides, service manuals, and instructions for use (IFUs).

• Partner with our software translation vendor to perform translation on the instrument and verify for consistency

• Manage translation projects with the translation vendor and perform translation reviews for consistency with formatting and layout.

• Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.

• Process documents through the electronic documentation control system (LSQM).

• Manage all aspects of document development and assist in production release, including draft reviews.

• Coordination of translations for documentation and software development.

• Ensure compliance of labeling with all applicable regulatory/QSR requirements.

• Create and edit documentation in compliance with requirements from applicable regulatory bodies (FDA, IVDR, EUDR) and the European Union (EU Medical Device Regulation).

• Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews, and verification deliverables.

• Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.

• Continually review the document development process to ensure quality in labeling output.

• Assist Validation team in the validation of Manuals

• Support internal technical editors in the translation process

• Support software user interface translation process

• Keep track of documentation through the entire development process while adhering to time lines, maintaining revision control, maintaining change lists, and managing reviews

• Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style.

Knowledge, Skills, and Abilities

• Advanced writing/editing skills

• Self-directed and highly organized

• Ability to manage multiple priorities

• Excellent communication skills

• Cross-functional collaborative nature

• Proven ability to work with global stakeholder

• Familiarity with quality processes and principals

• Product lifecycle management software experience

• Medical terminology experience

• Product development workflow experience

• Hands-on experience with instrumentation and software

Education

Bachelor's degree, preferably in English or Technical Communication, similar related fields.

Experience

Minimum five years of experience writing end-user software or hardware instructions.

Experience in the medical device industry preferred

Experience working in a federally regulated environment (FDA/UMDR)

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists the neck. Light to moderate lifting and carrying objects with a maximum lift of 35 lbs. Frequently drives to other facilities. Able to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others and relates sensitive information to diverse groups.

Pay Scale

The estimated pay scale for this Instrument Documentation Writer role based in San Diego, CA, is $87,575 to $109,469 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 519712

Type: Regular Full-Time

Job Category: Research & Development