ppWould 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 general 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. /p pbWe 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. /b /p h3Mission /h3 pSupport 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. /p h3What your responsibilities will be /h3 ul libParticipation in defining instrument-related aspects of the diagnostic technique to be automated: /b ul liAnalyze the steps of each diagnostic technique to be performed by the instrument. /li liSupport the integration of the Grifols IVD instruments with TLA tracks,middlewaresand LIS systems. /li liParticipate in establishing the interface requirements for TLA integration and parameters for each of the diagnostic technique those steps( interfaceinformation and timings, sample volume, aspiration/dispensing speed, number of cycles, etc.). /li liVerify that instruments perform diagnostic techniques correctly. /li /ul /li libIVD Systems verification /b ul liAnalyze and draft final verification reports. /li liCollect data. Draft and/or execute Design Verification protocols at both integration level and product requirement level. /li liPerform regression analysis and testing.



/li liEvaluate deviations found in verification protocols and regression tests. /li liEnsure cleanliness, order, and compliance with occupational health and safety standards in the lab. /li /ul /li liReview design requirements and specifications to identify and determine critical aspects and ensure completeness. /li liUnderstanding of TLA IT infrastructure and network solutions (instrument connections, firewalls, LIS and LAS). /li liProvide support to other departments regarding instrument and software functionality. /li liGenerate and update project-specific documentation (technical reports, instructions, analytical methods, etc.). /li liReview project-related documentation generated by other departments (User Manuals). /li liParticipate in Product Design Risk Analysis. /li liEnsure that instruments, materials, and reagents used meet defined requirements. /li liParticipate in the training of other team members. Advise other users of IVD systems. /li libAnalysis of complaints /b ul liAnalyze complaints related to deficiencies in the diagnostic technique and system TLA integration to determine root cause and potential solutions. /li liInterpret instrument and software interface logs (HL7, ASTM, RS-232 protocols) to c onduct investigative studies on product-related complaints. /li /ul /li /ul h3Who you are /h3 pTo 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).



/p ul liBachelor’s Degree in Engineering (Biomedical, Electronic, Industrial or related field). /li liMinimum of 3-5 years of experience in medical device or automotive industry, working in environments with regulated processes and high documentation standards. /li liYou have strong communication skills, and are able to interact effectively with global manufacturers, internal teams, and external stakeholders. /li liStrong problem-solving skills and willingness tothink outside the boxand roll up one’s sleeves to get the job done. /li liCertifications (nice to have): knowledge of IVDR, ISO 13485, and 21CFR820. /li liAdvanced in English is a must. /li /ul h3What we offer /h3 pIt 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. /p pInformation about Grifols is available at /p h3Flexibility for U Program: /h3 pHybrid Model /p h3Flexible schedule: /h3 pMonday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time). /p h3Contract of Employment: /h3 pPermanent position /p pbGrifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. /b /p pGrifols is an equal opportunity employer. /p /p #J-18808-Ljbffr

📌 SYSTEMS ENGINEERING SPECIALIST (San Cugat del Vallés)
🏢 Grifols
📍 San Cugat del Vallés