Scientific Technical Writer- Medical Devices- Autoimmunity

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Scientific Technical Writer will be responsible for creating, editing, and maintaining high-quality documentation for Biotech IVD instrumentation and reagent projects. This includes authoring and revising CAPAs (Corrective and Preventive Actions), V&V (Verification & Validation) reports and protocols, and other quality and regulatory documents. The position supports the R&D and Quality teams by ensuring all documentation meets internal standards and regulatory requirements.

Key Accountabilities

• Develop, edit, and maintain technical documentation, including CAPAs, V&V reports, protocols, and quality documents for in-vitro diagnostic instruments.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to gather information and ensure accuracy and completeness of documentation.
• Ensure all documents comply with company procedures, regulatory standards, and design control requirements.
• Participate in document reviews, audits, and updates as required.
• Support the creation and maintenance of Design History Files (DHF) and other records as needed.
• Translate complex scientific concepts into clear, concise, and accurate documentation for internal and external audiences.
• Communicate effectively with cross-functional teams to clarify requirements and resolve documentation issues.

Networking/Key relationships

• R&D teams: Assay Development and Biomarker discovery
• Manufacturing and Operations Teams
• Quality & Regulatory Teams
• Global Systems Support
• Software and Hardware Teams (within Werfen or external)

Minimum Knowledge & Experience for the position:

Bachelor's in Life Sciences, Engineering, or related field (Master's a plus). At least 3 years' technical writing experience in biotech, medical device, or IVD sectors.

Skills & Capabilities:

• Experience with design control processes and document control systems.
• Familiarity with V&V documentation, CAPA processes,and quality management systems.
• Strong attention to detail, organizational, and communication skills
• Proficiency with Microsoft Office (Word, Excel, Acrobat).
• Experience with in-vitro diagnostics or medical device documentation.
• Knowledge of regulatory standards (FDA, ISO 13485, etc.).
• Ability to work independently
• Ability to manage priorities across multiple projects simultaneously.

Travel requirements:None required.

The hourly range for this role is currently $36.00 range to $46.00 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com