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Sr. Manager, Clinical Systems Engineering

Company: Thermo Fisher Scientific
Location: Austin
Posted on: November 22, 2021

Job 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
* How will you make an impact?*
Join the forefront of innovation in genetic analysis for research & clinical applications! Our teams develop platforms, consumables, and reagents that help [bring offenders 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, backed by the resources of a $25B enterprise, our technologies have significant impact worldwide. With our team, you can play a meaningful role in helping us fulfill our global mission of making the world healthier, cleaner, and safer.
As a Senior Manager, you are key to providing direction and focus to drive division objectives. You will build, lead and develop a team that defines system aspects for product development in collaboration with highly technical and specialized engineering professionals and scientists to develop instruments and applications for our platforms in multiple sectors. You will develop and implement systems engineering methodologies and improve the planning capabilities of the organization. As an agent of change, you'll build a culture of quality while maintaining a bias for action and innovation. By developing existing talent and recruiting new talent, you'll extend the systems engineering proficiency of the current team and support the introduction of new diagnostic products in multiple regulatory markets, including RUO, CE, IVDR, and 510(k).
* What will you do?*
* Participate in new product introductions as a member of a multi-functional core team
* Understand clinical customers and optimally translate their needs to product requirements (experience in usability engineering is a plus)
* Partner with Product Management to define system architecture, integration design, development, and feasibility testing
* Work with subsystem owners to architect and develop integrated systems from beginning to end for clinical workflows including leading stage gate design reviews, DFMEA & PFMEA processes, and design documentation
* Capture, prioritize, track and drive closure on issues including risks and mitigation plans
* Plan, develop, and analyze system integration with subsystem owners to maintain requirements traceability through verification
* Contribute to data-driven decision making by crafting experiments, analyzing data, and communicating results
* Work hand-in-hand with the Operations team to transfer your products into manufacturing.
* Develop and recruit talent to form a team of systems engineering guides to support assay and/or platform development projects
* How will you get here?

* Degree(s) in a technical Engineering field or Applied Physics (Minimum: BS, Preferred: MS or PhD)
* 8+ years developing life science or clinical instrumentation, consumables, and assays (preferred) or medical devices in an R&D setting
* 3+ years as technical lead in new product development
* 2+ years serving regulated markets in a commercial environment
* Track record of delivering successful products (RUO or IVD) with a detailed understanding of quality systems
* Participation as R&D core team member for at least one complete product development cycle for an IVD or medical device
* Previous experience working with regulatory teams and knowledge of regulatory agency requirements including: QSR (21 CFR -- 820.30 and -- 11), ISO 13485, IEC 62304, and other international regulatory requirements
* Shown success working across multi-disciplinary and multi-functional teams including scientists, engineers and software personnel in a global matrixed environment, encouraging collaborative relationships and building credibility across functions and teams
* Recruited, mentored and developed junior staff and empowered teams to develop impactful strategies and plans
* Demonstrated ability to implement systems engineering practices
* Knowledge, Skills, Abilities:*
* Expertise in systems engineering processes, from requirements capturing and risk analysis to statistical power in validation
* Ability to write requirements and apply requirements management tools
* High level of professional expertise and familiarity with current engineering/scientific literature, related technologies, and/or products as well as attendance at seminars and meetings
* Excellent organizational skills, including the ability to efficiently evaluate, prioritize and balance multiple and changing programs or projects
* Understanding of cybersecurity standards and implementation tools; knowledge of ISO and FDA cybersecurity guidance
* Ability travel up to 25% (domestic or international)
* This position has been approved for relocation assistance.*
Our global team of more than 90,000 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 [](

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.

* EVRD2020 *GTSDouble

Keywords: Thermo Fisher Scientific, Austin , Sr. Manager, Clinical Systems Engineering, Executive , Austin, Texas

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