IVD Systems Specialist

Participation in defining instrument-related aspects of the diagnostic technique to be automated:

• Analyze the steps of each diagnostic technique to be performed by the instrument.
• Support the integration of the Grifols IVD instruments with TLA tracks, middlewares and LIS systems.
• Participate in establishing the interface requirements for TLA integration and parameters for each of the diagnostic techniquethose steps (interface information and timings, sample volume, aspiration/dispensing speed, number of cycles, etc.).
• Verify that instruments perform diagnostic techniques correctly.

• IVD Systems verification

• Analyze and draft final verification reports.
• Collect data. Draft and/or execute Design Verification protocols at both integration level and product requirement level.
• Perform regression analysis and testing.
• Evaluate deviations found in verification protocols and regression tests.
• Ensure cleanliness, order, and compliance with occupational health and safety standards in the lab.

• IVD systems support:

• Review design requirements and specifications to identify and determine critical aspects and ensure completeness.
• Understanding of TLA IT infrastructure and network solutions (instrument connections, firewalls, LIS and LAS).
• Provide support to other departments regarding instrument and software functionality.
• Generate and update project-specific documentation (technical reports, instructions, analytical methods, etc.).
• Review project-related documentation generated by other departments (User Manuals).
• Participate in Product Design Risk Analysis.
• Ensure that instruments, materials, and reagents used meet defined requirements.
• Participate in the training of other team members. Advise other users of IVD systems.

• Analysis of complaints

• Analyze complaints related to deficiencies in the diagnostic technique and system TLA integration to determine root cause and potential solutions.
• Interpret instrument and software interface logs (HL7, ASTM, RS-232 protocols) to conduct investigative studies on product-related complaints.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

• Bachelor's Degree in Engineering (Biomedical, Electronic, Industrial or related field).
• Minimum of 3-5 years of experience in medical device or automotive industry, working in environments with regulated processes and high documentation standards.
• You have strong communication skills, and are able to interact effectively with global manufacturers, internal teams, and external stakeholders.
• Strong problem-solving skills and willingness to think outside the box and roll up one's sleeves to get the job done.
• Certifications (nice to have): knowledge of IVDR, ISO 13485, and 21CFR820.
• Advanced in English is a must.

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. We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment. Mission Support verification activities of instruments, mainly those related to product requirements and those derived from modular design integration. This role is responsible for conducting system evaluations across both the instrument and reagent set, as well as leading studies focused on performance optimization. It also delivers advanced troubleshooting at the system level and supports the integration of hardware and software within total laboratory automation (TLA) for IVD devices., It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.