Andy Golden work email
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Andy Golden personal email
Sr.-level versatile R&D Manager/Team Leader with 12+ years of industry experience in development & commercialization of medical devices & research tools/platforms. End-to-end technical understanding of what it takes to develop and scale novel diagnostics for a variety of assay/platforms including micro/nano-fluidic applications for high throughput clinical applications. Expert in designing, testing via experimentation, technologies for robustness. Outstanding root-cause/statistics/data analytics skills. Collaborative leadership & managerial style that bridges disciplines, helps define & clarify goals, fosters collaboration, and supports risk-taking/excellence. Seeking new opportunities with teams working on products with significant market potential.Some of the projects I'm proud to have worked on include:• Developing 7 complex fluidic disposable products in IVD and other markets.• Led 2 work streams leading to FDA submission for novel POC molecule platform using CRISPR in < 24 mo’s.• Successfully Led/participated in multiple complex high-value root-cause analysis/projects throughout development lifecycle.• Supported R&D activities for 3 products that were ultimately commercialized: 1 implant and 2 that were RUO. • Hired, develop and managed 15+ engineers/scientists, supervised team of 6, led multiple X-functional efforts.• Multiple successful patent work-arounds and 65+ patent apps.Interested in medical/IVD device/consumables development? Feel free to connect!
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Principal EngineerLightforceBoston, Ma, Us -
Director, Engineering Consumables / Process DevelopmentProof Diagnostics, Inc. 2020 - PresentCambridge, Massachusetts, United States• Acquired by Ginkgo Bioworks• R&D Lead for microfluidic cartridge team. • Drove product and process development including: $1MM+ effort to control assembly of innovative valving approach, shelf life optimization, FDA submission support, and Next-Gen design and breadboarding. • Lead for lyophilized reagent beads from Phase 0 through manufacturing readiness.• Managed partnership with lyo CMO including transfer to production line, scale-up studies, 26 lots, master mix formulation / QC qualification, and documentation. • Led the calling algorithm analysis and optimization through EUA submission.• Provided need, vision, and approach for a process analytics database. Worked with digital team to enable. -
Sr. Engineer & Team LeadInstrumentation Laboratory 2019 - 2020Greater Boston Area• Managed the technology development team within engineering.• Successfully lead feasibility work for modules of microfluidic blood cartridge including plasma separation, bubble handling & reagent mixing.• Established cross-functional and external relationships.• Developed new QC tests to support yield / process improvement with Process and Development teams for on-market cartridge.
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Director, ConsumablesGenturi 2016 - 2019Greater Boston Area• Built and managed a small internal team and managed an external partner.• Successfully led nanofluidic consumable development from academic prototype to mass manufacturable device. Required new QC tests to achieve nanoscale bonding precision for plastic chips (2 pending patent applications). • Led coating development for single molecule DNA transport, resulting in an unconventional set of coatings and on-board QC tests. • Hired and managed technical team.• Developed IP strategy & completed multiple filings. -
Senior Scientist / Team Lead For Manufacturing Process ResearchAgamatrix 2014 - 2016• R&D manager / team lead for scientific and engineering projects that integrate sample and reagent with the diagnostic consumable. • Managed collaboration with mechanical engineering / manufacturing department. • Invented and developed a novel coating and test strip geometry, then transferred technology to factory. • Led interdisciplinary effort to reduce test strip variability, guided by statistical methods. -
Sr. R&D EngineerLemaitre Vascular 2012 - 2014Burlington, Massachusetts, United States• Developed XenoSure bovine pericardial patch for vascular implantation, from product transfer through 510k FDA approval and manufacturing scale-up. • Designed and implemented suite of chemical quality control tests for chemicals that contact product during processing, fixation, sterilization, and packaging. • Wrote >50 documents for DHF. • Invented 3 surgical bioglues, 2 which diverged from competition, filed 8 patent disclosures. • Implemented design control (21 CFR 820) and ISO 13485. -
Scientific ConsultantMinotech Engineering 2008 - 2014Fiberoptic picotiter plates for genomic sequencing and other life science tools. R&D and prototype fabrication for customers.
Andy Golden Education Details
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Biomedical Engineering -
Novartis Institute For Biomedical Research (Nibr)Presidential Post Doctoral Fellow -
Mechanical And Aerospace Engineering
Frequently Asked Questions about Andy Golden
What company does Andy Golden work for?
Andy Golden works for Lightforce
What is Andy Golden's role at the current company?
Andy Golden's current role is Principal Engineer.
What is Andy Golden's email address?
Andy Golden's email address is an****@****tho.com
What schools did Andy Golden attend?
Andy Golden attended Boston University, Novartis Institute For Biomedical Research (Nibr), Cornell University.
Who are Andy Golden's colleagues?
Andy Golden's colleagues are Kattia Bartels, Gabriel Villegas, Brandon L., Antonio Saravia, Abby Kesselman, Carlos Melgar, Andres Rojas.
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Andy Golden
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