Systems Verification and Validation Senior Scientist
Our client, a medical device company in Limerick is currently looking to recruit a Systems Verification and Validation Senior Scientist for their site.
- The Systems Verification and Validation (SVV) Senior Scientist leads the definition, design, and execution of SVV activities throughout all phases of the product development process for cellular analysis systems.
- This includes the design of test methods and test strategy, development and execution of formal protocols, analysis and interpretation of results, and communication of results and their impact through written reports, design reviews, and interactive discussions.
- The Senior Scientist works closely with senior management, systems engineering, marketing, and the product development team to support the successful application of new technologies and ensure that the system design meets technical, customer, and regulatory agency requirements.
- He/She is a highly trusted individual who exercises sound, independent judgment and applies systems thinking, problem solving, debugging, and troubleshooting to generate innovative ideas to improve products or processes.
- The SVV Senior Scientist is a V&V team leader and cross-functional program representative.
- The Senior Scientist conducts experiments using flow cytometry and applies strong knowledge in scientific principles, immunology, sample manipulation, and/or immunoassays to influence best practice laboratory procedures and study designs.
- The individual maintains up-to-date knowledge of customer workflows, scientific advancements in flow cytometry and the competitive landscape.
- He/She acts as an interface between customers and developers/testers by translating customer needs into product requirements and testing workflows.
- He/she understands and communicates the broader impact of design features, test methods, and results to the user, customer, regulator and to the marketability of the product.
- The SVV Senior Scientist leads projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives, and directs large sized teams.
- The individual serves as a technical contributor on cross-functional teams, exercising influence across functions, and provides input to senior management on strategic and functional decisions.
The successful candidate will possess:
- Typically requires a minimum of a Bachelor’s Degree in Immunology, Cell Biology, or Clinical Laboratory Science with a minimum of 5 years relevant experience or a combination of equivalent education and experience.
- Typically requires B.S. or M.S. in Immunology, Cell Biology, Clinical Laboratory Science or related scientific discipline with a minimum of 5 years experience in clinical, research, pharma, medical device or other relevant industry
- Extensive hands on experience operating and troubleshooting flow cytometry analyzers and/or sorters, with knowledge of flow cytometry instrument platforms, applications and software, assay panel development and customer workflows
- Extensive experience designing and optimizing multi-parameter flow cytometry applications which may include: immunophenotyping, apoptosis, cell proliferation, cell activation, receptor expression, and/or intracellular calcium flux
- Proven ability to execute complex experiments independently, perform in-depth statistical analysis, interpret experimental results, and make sound conclusions • Proven ability to apply creative problem solving skills to novel or complex applications • Proven ability to critically evaluate proposed study designs with strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power
- Experience training bench-level personnel at multiple levels of education and/or expertise • Strong interpersonal skills with a proven ability to collaborate with others in multi-disciplinary team settings, influence decision making, and build group consensus
- Excellent written and oral communication skills
- Demonstrated success leading medium to large sized projects, with the ability to meet technical objectives and solve complex challenges under conditions of ambiguity and rapid change
- Experience managing timelines, budgets, and resources using project management tools such as PDWare, Microsoft Project, PERT charts, and Gantt charts
- Experience handling and processing infectious blood samples in a Biosafety Level 2 laboratory using universal precautions
- (Preferred) MS or PhD degree in Immunology, Cell Biology or in a related scientific discipline
- Strong knowledge of HIV, leukemia, lymphoma, hematology, and/or cancer biology
- Experience with genomics instrumentation, applications, and customer workflows
- Experience in human factors or usability engineering principles or studies
- Experience working within a regulated medical device industry with knowledge or experience in FDA submissions
- Familiar with accreditation and guiding agencies for the clinical laboratory including CAP, CLIA, and CLSI, including experience in audits conducted by accrediting bodies
For further information on this Systems Verification and Validation Senior Scientist role in Limerick please contact Anna McGowan on 0864667369 / email@example.com
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