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Thermo Fisher Scientific Algorithm Validation , Software Integration Engineer in South San Francisco, California

Job Title – Algorithm Software Integration Engineer

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 - US-South San Francisco OR Pleasanton, CA

How will you make an impact?

You will be a part of the fast-growing field of Clinical Diagnostics developing algorithms for molecular diagnostics based on real-time PCR technologies. of assay, reagents, software, hardware designers and manufacturing will revolutionize healthcare through high throughput diagnostic systems. Thermo Fisher Scientific Inc. has played a pivotal role in the COVID-19 pandemic with the TaqPath COVID-19 Combo Kit for testing SARS-CoV-2. We continue to innovate and provide new solutions for the pandemic and we need your talent to help save lives. This is a dynamic career opportunity to join as an Algorithm SW Integration Team member to support our qPCR Algorithm Development Group.

We are developing an automated workflow for COVID-19 testing using liquid handlers, nucleic acid purification systems and real-time PCR instrumentation. The software experience is essential in providing users an easy to operate solution that minimizes hazards and the software system must be evaluated for use by trained personnel conducting clinical molecular tests.

What will you do?

  • Comprehend current and legacy qPCR Processing Algorithms and integrate into a Test Harness.

  • Develop, write and perform Algorithm Integration Testing Protocols that comply with 510K Standards and Regulatory bodies

  • Define application interfaces between components, drive standards for data transfer

  • Organize and data mine / annotate clinical data to assess the performance of clinical tests

  • Use Instrument Knowledge to help troubleshoot data anomalies

  • Work closely with scientists and engineers with data analysis & experimental design

  • Collaborate and communicate with various teams and business units

How will you get here?

  • Education

Masters’s degree in Molecular Biology, Biology, Chemistry, Applied Mathematics, Physics, Electrical Engineering, Computational Biology, Biostatistics, Bioinformatics, Biomedical, Computer Science or related discipline, PhD a plus.

  • Experience

  • 5+ years of product development experience (Biomedical, Instrument Integration, good understanding of qPCR Technology highly preferred)

  • Excellent programming skills in C++, Java and Python

  • Experience utilizing Matlab, JMP, R, PowerBI or SPSS

  • Experience working in regulated / validated environment is a major plus

  • Prior hands on experience with data structures, algorithms, operating systems, and distributed systems fundamentals.

Knowledge, Skills, Abilities

  • Understanding of clinical trial design and evaluation

  • Knowledge in Molecular Biology and Clinical Diagnostics

  • Strong understanding of qPCR and amplification curve data

  • Prior experience with US-FDA 510k product development/submission, 21 CFR Part 11, and ISO 13485 is highly preferred

  • Ability to present and communicate analytical and clinical study analysis results to non-experts

  • Ability to work independently and in a team environment

  • Highly data-driven/detail oriented and ability to understand individual's results effect at a Software Level.

Our global team of more than 75,000 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 .

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.