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Sr. Staff Systems Engineer

Thermo Fisher Scientific

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Posted on 05/18/2022

Location

Austin, Texas

Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Location/Division Specific Information:

  • Austin, TX
  • Genetic Sciences Division

Join the forefront of innovation in genetic analysis for research & clinical applications. Our teams develop platforms, consumables, and reagents that help bring criminals to justice, ensure reproductive health, accelerate disease research, advance methods for syndromic testing of infectious diseases and viruses, and keep the world’s food supply safe. As the leading provider of genetic analysis solutions and leveraging the resources of a $24B enterprise, our technologies have great impact worldwide. And as a member of our team, you can play a critical role in helping us fulfill our global mission of making the world healthier, cleaner, and safer.

How will you make an impact?
Sr. Staff Engineers are technical leaders in the R&D function and are key to defining and developing instrument and consumable products in the Genetic Sciences Division. This individual leads system definition & system integration aspects of product development in collaboration with highly technical and specialized engineering professionals and scientists to develop instruments and applications for our world class qPCR, Capillary Electrophoresis, Rapid DNA, and Microarray platforms in both RUO and IVD markets.

Major Duties & Responsibilities

What will you do?
The Sr. Staff Systems Engineer will be responsible for providing direction and focus to drive Division objectives as follows:

  • Partner with our Product Management teams to define system architecture and design, development, feasibility testing, development, integration, validation, and post-market support
  • Understand clinical customers and effectively translate their needs to product requirements, experience in usability engineering is a plus
  • Work with cross-functional subsystem owners to design and develop integrated systems from beginning to end of the clinical sample workflow(s) including leading stage gate design reviews, d/pFMEA processes, and design documentation
  • Develop integrated systems and automated workflows
  • Develop best practices for the development, configuration management and testing of systems using scripted languages to control automation
  • Develop best practices for configuration management during system level V&V
  • Develop and execute V&V plans for automated systems
  • Work closely with field teams during post-market launch to troubleshoot and resolve customer issues.
  • Author design control documents to support the introduction of new diagnostic products in all categories: RUO, 510K and CE IVDR
  • Work hand-in-hand with the Operations team to transfer your products into manufacturing

Minimum Skills & Abilities

How will you get here?
Educducation/Experience:

  • BS degree in an Engineering discipline MS/Ph.D. preferred.
  • 7+ years in a life science instrumentation, consumables, and assays in R&D setting, preferably in genomics
  • 3+ years as technical lead in new product development
  • 2+ years serving regulated markets in a commercial environment
  • Experience serving regulated markets in a commercial environment
  • Track record of delivering successful RUO and IVD products with a thorough understanding of quality systems
  • Experience developing products in regulated markets for 510K clearance or CE marking. IVDR experience is desirable.
  • Demonstrated experience working across multi-disciplined teams / cross - functional teams – scientists, engineers, software, quality, and regulatory personnel. Demonstrated success at networking
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs/projects and priorities
  • Demonstrable experience in troubleshooting and root cause analysis of complex systems. Critical thinking mindset mixed with creativity and a knack for problem solving

Key experiences should include:

  • Experience in developing moderate to high complexity integrated life sciences or clinical instrumentation, consumables, and software in an IVD environment
  • Experience programming automated schedulers and liquid handlers. Demonstrated ability to map workflows to identify critical areas and/or optimize processes and to develop and execute test plans to validate those workflows
  • Experience in systems engineering processes, from requirements gathering and risk analysis to statistical power in validation is a plus
  • Experience in Reliability Engineering is a plus
  • An understanding of genetic analysis tools, workflows, and chemistry in at least one of these areas: CE Sanger sequencing, qPCR, microarray, or sample preparation

Key people attributes:

  • Fosters collaborative relationships and builds credibility across functions/teams
  • Inspires, influences, and empowers employees across a global matrix to achieve goals
  • Able to decisively lead and empower teams to develop impactful strategies and plans
  • Maintains a high level of professional expertise through familiarity with current engineering/scientific literature, competing technologies, and/or products as well as attendance of seminars and meetings.

Knowledge, Skills, Abilities:

  • Ability to think critically and desire to drive constant improvement
  • Highly data-driven/detail oriented and ability to understand individual's results effect on a systems level
  • Excellent communication skills both written and verbal
  • Ability to work cross-functionally and within multidisciplinary teams
  • Willingness to travel up to 25%, domestic or internationally

Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Minimum Education & Experience

BS degree in an Engineering discipline MS/Ph.D. preferred. 

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