Product Development Specialist
Sant Cugat del Valles, ES
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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. |
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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 also carries out activities to evaluate the system (instrument + reagent set) and all studies aimed at optimizing its performance.
What your responsibilities will be
- 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.
- Participate in establishing the parameters for each of those steps (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. May delegate certain tasks (mainly execution and data collection).
- Collect data. Draft and/or execute Design Verification protocols at both integration level and product requirement level.
- Perform regression 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.
- 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 to determine root cause and potential solutions.
- Conduct investigative studies on product-related complaints
Who you are
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 2 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 manufacturers, internal teams, and external stakeholders.
- Certifications (nice to have): knowledge of IVDR, ISO 13485, and 21CFR820.
- Advanced in English is a must.
What we offer
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.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
Grifols is an equal opportunity employer.
Flexibility for U Program: Hybrid Model
Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
Benefits package
Contract of Employment: Permanent position
Location: Sant Cugat del Vallès.
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Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]