Thermo Fisher Scientific Systems Verification and Validation Staff Engineer Scientist in South San Francisco, California
Job Title: Staff Engineer - Systems Verification and Validation
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
South San Francisco, CA | Genetic Sciences Division
How will you make an impact?
- You will be responsible for defining, designing, and executing system verification and validation activities throughout all phases of the product development lifecycle process for analysis systems such as qPCR, Automation, Sequencing and Microarray for research and clinical applications. He/she will work closely with and influence systems engineers, marketing, and the product development team to enable the successful application and integration of new technologies, including hardware, software, and reagents in Thermofisher products.
What will you do?
He/She influences the product design by contributing innovative ideas, assessing the suitability of design architectures and features to meet the needs of the customer, and ensuring the quality of the product through rigorous testing.
In addition, he/she participates in customer engagement activities to thoroughly understand customer needs and assist product development teams in translate these customer needs to measurable technical specification and product requirements.
He/she will design, plan, and conduct experiments to assess the technical capability, feasibility, and performance of sub-systems and systems. He/she keeps abreast of technology advancements, and leads initiatives to drive more reliable, efficient, and effective verification testing, such as automated test fixtures, simulation and analysis capabilities, while satisfying the expectations of regulatory stakeholders.
He/She will maintain up-to-date knowledge of customer workflows, scientific advancements in capillary electrophoresis, qPCR and/or Microarray while ensuring proximity to the competitive landscape. In doing so, they will be expected to assist in translating customer needs into product requirements by understanding the broader impact of design features and results to the user and regulator.
Manage test method and strategy design; protocol execution; data analysis and communication to project and business stakeholders. The individual understands and communicates the broader impact of design features, test methodologies and strategies, and results to the end-user, customer and to the marketability of the product. He/she understands and appreciates the customer need, and acts as a customer advocate to product development teams to ensure that the right product is built. He/she will be called upon to represent the voice of the customer to product developers, and assist with translating the customer needs to product requirements, specifications, and test methods to ensure needs are met. The individual understands and communicates the broader impact of design features, test methods, and test results to the end-user, customer, regulator, and to the marketability of the product.
He/She will be a pivotal member of the development team and assist in problem solving and troubleshooting to improve current and future products in development. Thus, the individual will be expected to exercise influence across functional teams and provide input to management on strategic decisions.
Will engage in hardware/software integration testing, performance characterization, requirements analysis, test design, test execution, defect and customer complaint root cause investigations, and risk and hazard analysis. This individual is an excellent systematic troubleshooter, combining a thorough understanding of the product's subsystems - how they function and interact with each other - with knowledge of customer needs and workflows to solve problems.
How will you get here?
- B.S. or M.S. in Bioengineering, Systems Engineering, Chemical Engineering, Molecular Biology, or related scientific discipline with a minimum of 8 years' experience in product development for clinical, research, pharma, medical device or other relevant industry
Hands on experience operating and troubleshooting capillary electrophoresis, qPCR, Automation and/or Microarray instrumentation with knowledge of applications, software, assay development and customer workflows
Hands on experience working with Applied Biosystems/Thermo Fisher capillary electrophoresis instrumentation is highly desirable
Ability to quickly grasp the functionality and interdependencies of complex multidisciplinary systems, to include lasers, optics, fluidics, electro-mechanical devices, software, algorithms, biological samples, and biochemistry.
Proven ability to execute complex experiments independently, perform statistical analysis (the calculation of sample sizes and/or estimation of statistical power), interpret experimental results, and make sound conclusions
Knowledge, Skills, Abilities
Ability to understand the broader impact of design features, testing methods, and test results to the user, customer, regulator, and to the marketability of the product.
Ability to critically evaluate proposed study designs
Proficient in data extraction, manipulation, and interpretation
Previous experience in writing and executing system level validation protocols
Demonstrated knowledge and application of fundamental engineering concepts, developing good requirements as well as product development process and design control
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.