Thermo Fisher Scientific Automation & Process Engineer in Austin, Texas
Automation & Process Engineer
What will you do?
Partner with our Product Management team to define system architecture, integration design, development plans, and feasibility testing.
Understand clinical customers and effectively translate their needs to product requirements
Develop sample prep protocols for clinical samples on liquid handler instruments (Hamilton, TECAN) to be compatible with downstream assays.
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.
Plan, develop, and analyze system integration in order to maintain requirement traceability through various subsystems and verification activities in collaboration with subsystem requirements owners
Contribute to data-driven decision making by designing experiments, analyzing, and presenting results
Work together with the Operations team to transfer your products into manufacturing or other R&D teams.
How will you get here?
BS/MS. degree in an Engineering, Applied Physics or Molecular Biology or other scientific discipline.
3-5 years experience with life science instrumentation, consumables, and assays in R&D setting, preferably in genomics
Expertise with automated liquid handlers such as Hamilton or TECAN systems including programming/scripting
1-2 years experience as technical lead in new product development
1-2 years experience serving regulated markets in a commercial environment
Track record of delivering successful RUO and IVD products with a thorough understanding of quality systems
Demonstrated success working in a global matrixed environment & willingness to travel up to 10%, domestic or internationally
Knowledge, Skills, Abilities:
Considerable experience in developing moderate complexity integrated life sciences or clinical instrumentation, consumables, and software in an IVD environment
Demonstrable expertise in systems engineering processes, from requirements gathering and risk analysis to statistical power in validation
A solid understanding of genetic analysis tools, workflows, and chemistry in at least one of these areas: qPCR and/or sample preparation
Demonstrated experience working across multi-disciplinary, cross-functional teams of scientists, engineers and software personnel. Demonstrated success at networking across the company.
Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs, projects and priorities.
Experience in working with regulatory teams and knowledge of regulatory agency requirements. This includes, QSR - 21 CFR 820.30, 21CFR Part 11, ISO13485, ISO62304, and international regulatory requirements
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.
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.
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