Jan Thompson Email & Phone Number

Sole systems engineer in charge of supporting integration activities for all Grifols’ NAT (nucleic acid technology) in-development and on-market RUO, CE-IVD, and IVD blood screening assays. Managed a team of engineers responsible for maintaining the operational capability of over 40 NAT instruments in R&D and Quality Control departments, including installation, troubleshooting, preventative maintenance, and software changes:• Owned all systems engineering activities on cross-functional core teams, including authoring system-level requirements and specifications, V&V plans, testing, traceability, and risk mitigation activities to verify system-level requirements are met.• Aided in the development of guardband, co-existence, and intended use testing to ensure performance is optimized and no timing conflicts are introduced with the release of additional assays. • Managed technical communication and supported investigation of software, hardware, and reliability issues with NAT instrumentation manufacturer. • Participated in project for new product development through authoring SOW, owning Product Requirements Document, engaging and managing communication with potential OEM partners, and reviewing proposals.

Agilent Technologies acquired Lasergen in May 2018.

Key contributor to Agilent’s $185M acquisition of Lasergen, a start-up company developing clinically relevant Next-Generation Sequencing instrumentation.Acted as a member of a small core team on fabrication, assembly, and testing of multiple prototypes following ISO 13485:• Owned, planned, executed, and delegated system integration testing, verification, and validation activities.• Drove traceability efforts from customer requirements to system level requirements and low-level specifications.• Participated in design reviews, DFMEA, and other risk mitigation activities.• Led technical characterization testing of fluidics subsystem.• Developed and executed training programs for internal team on setting up and running multiple system iterations.Provided unique perspective to system integration role through extensive sequencing experience, product development proficiency, and understanding of application:• Established measurable performance links between instrumentation, chemistry, and consumables.

Agena Bioscience acquired the Genetic Analysis division of Sequenom in May 2014.

Greater San Diego Area

Evaluation of Next-Generation Sequencing (NGS) platform for use in clinical laboratories:• Develop expertise in both the individual components of the system and the interdependencies of these components, including hardware, software, sequencing chemistry, and data analysis.• Design, conduct, and analyze experiments targeted to optimize instrument performance and demonstrate technical feasibility.• Experience with both ligation- and polymerase-based sequencing chemistries.Class II 510(k) submissions:Integrate systems and develop products in accordance with 21 CFR, ISO 14971, ISO 13485 and Sequenom’s Design Control Process in support of dual Class II 510(k) submissions of in vitro diagnostic (IVD) medical device using MassARRAY (MALDI-TOF) platform and Factor V Leiden, Factor II genotyping tests. Participate as a core team member responsible for scheduling and executing deliverables for both these submissions in addition to a 510(k) submission of molecular diagnostic instrument with combined functions using MassARRAY platform. • Develop and author requirements, specifications, and tests using Dynamic Object-Oriented Requirements System (DOORS).• Conduct design verification and validation through authoring protocols, executing system-level performance and environmental testing, and training testers on hardware and software sub-systems.• Improve product functionality by investigating, risk assessing, troubleshooting, and solving system-level defects and anomalies.• Collaborate with cross functional teams, including software development, biological and systems research and development, engineering, manufacturing, quality, and regulatory.• Assist with software development by imaging systems and performing investigative testing, and verifying the remediation of software defects using JIRA.

Greater San Diego Area

• Prepared individual, partnership, corporation, S-corporation, and estate tax returns.• Managed client accounts by performing accounting data entry, creating general ledgers, and producing financial statements.