Grifols Shared Services North America, Inc Systems Engineer II, R&D in San Diego, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
This position is responsible for systems engineering for medical diagnostics systems, optimizing system interfaces and integrating subsystems including hardware, software, reagents and disposables.
Primary responsibilities for role:
Develops semi-automated fixtures using SolidWorks to test component reliability of IVD devices.
Responsible for designing and performing testing to optimize module functions of systems under development.
Responsible for designing and conducting studies to verify system performance.
Responsible for integrating instruments from different development groups in different locations into one system solution.
Responsible for working with development partners to solve technical issues.
Responsible for creating, reviewing and approving project documentation in accordance with design control processes.
Work with cross-functional members of project team to meet project goals
Conduct requirements management activities by creating, reviewing and managing requirements using VOC and business input.
Perform risk management activities in accordance with FDA and ISO regulations.
Investigate technical issues, determine root cause and resolutions.
Responsible for managing product configurations during development.
Create and conduct testing to support design and development of products.
Perform verification and validation activities as required.
Ability to plan your own work with minimal supervision, and work under tight timelines and be able to prioritize tasks.
Interacts with internal and external teams on fixture fabrication and validation."
Evaluate testing process workflows.
Perform instrument maintenance as required
Train as service engineer on platforms as needed
Service in-house platforms as needed
Perform instrument preventative maintenance as needed
Perform ad-hoc system testing
Report issues and software anomalies
Knowledge, Skills, and Abilities:
Ability to design fixtures using SolidWorks or equivalent CAD application.
Ability to investigate and document complex software defects and issues, for both product applications and computer/Operating Systems.
Knowledge of molecular biology is a plus.
Ability to work across multiple functions and geographic locations.
Ability to work under minimal supervision.
Ability to work under tight timelines and effectively prioritize several projects.
Excellent communication and interpersonal skills.
Experience testing instrument systems in development, including software.
Experience optimizing liquid pipetting a plus.
Hands on experience assembling fixtures.
Minimum requirement: Bachelor's Degree in a technical discipline such as Chemical Engineering, Biomedical Engineering, Life Sciences or equivalent.
Minimum of 5 years + Bachelor's degree or 3 years + Master's degree development experience in an IVD or medical device company. Experience with testing
instruments and software in development. Experience working in a regulated environment is a plus.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 457889