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Vacancy Details

Engineering & Technical

Systems Verification and Validation Senior Scientist - Limerick

Contract Type: Permanent
Sector:
Location: Limerick
Date: 8/06/2018
Job Reference: 96067

Job Description

Contact: Anna McGowan
Email: recruit@hero.ie
Telephone: 0864667369

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.

Job Description
Responsibilities
  • 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.

Qualifications
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

Desired:
  • (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 / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
More

Clients we are proud to work with

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