Website Werfen
Werfen
Company : Werfen
Introduction:
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.
Overview:
Job Summary
This role bridges clinical expertise in transfusion medicine with product innovation, supporting the development and optimization of diagnostic solutions that improve transfusion safety, efficiency, and outcomes. This position will utilize their deep technical expertise in serological and molecular blood banking to support the product pipeline.
Responsibilities:
Key Accountabilities
Clinical Expertise & Product Insight
- Serve as the internal expert on transfusion practices, immunohematology, and blood bank workflows.
- Provide clinical input into the design and development of new diagnostic assays, products, instruments, and software tools.
- Translate customer needs and regulatory requirements into product design inputs and specifications.
Innovation & Development Support
- Collaborate with R&D, engineering, and marketing teams to evaluate and develop novel technologies (e.g., molecular typing, next gen serology based testing, AI-assisted interpretation, automation).
- Participate in feasibility studies, usability testing, and clinical trials for new products.
- Analyze performance data and contribute to product performance testing and regulatory submissions.
Engagement & Education
- Support R&D teams as a consultant to help investigate technical challenges.
- Represent the company at scientific conferences, workshops, and customer meetings.
- Develop educational content to help build internal team competancies
Quality & Compliance
- Ensure all activities align with regulatory standards (FDA, CE-IVDR, ISO 13485) and industry best practices.
- Contribute to risk assessments, SOP development, and continuous improvement initiatives.
- Performs other duties and responsibilities as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships
- Identify, build, and maintain strong relationships with KOLs in transfusion medicine and immunohematology.
- Collaborate with KOLs on product evaluations, clinical studies, and advisory boards.
- Leverage KOL insights to inform product strategy, market positioning, and innovation priorities.
- Internally collaborate with Marketing, R&D, Clinical, Manufacturing, Regulatory, Quality
Qualifications:
Minimum Knowledge & Experience required for the position:
- Bachelor’s or Master’s degree in Medical Laboratory Science, Immunohematology, or related field.
- ASCP SBB (Specialist in Blood Banking) certification required
- Minimum of 5 years of experience in a transfusion service or blood center; industry experience preferred.
- Strong understanding of methodologies for blood group serology, molecular typing (PCR and NGS), antibody identification, and transfusion protocols.
- Experience with diagnostic product development, clinical trials, or innovation projects.
- Excellent communication, organizational, and problem-solving skills.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
- Familiarity with IVD product lifecycle and regulatory pathways.
- Experience with blood bank automation
- Strong communication and cross-functional collaboration skills.
- Ability to synthesize clinical needs into actionable product insights.
- Displays ability to be an effective team member with a stong passion for innovation
- Demonstrates strong verbal and written communication skills
Travel requirements:
As needed based on conferences and meetings to support the business objectives (10%).
Closing:
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or RESUME.
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 (url removed) 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.
(url removed)