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Instrument Manufacturing Engineer

Cambridge, MA · Manufacturing
About Vizgen:
Vizgen is a rapidly growing company commercializing the next generation of spatially resolved genomic profiling tools that enable researchers to gain new insight into the biological systems that underlie human health and disease. The company's groundbreaking MERSCOPE product utilizes MERFISH spatial transcriptomics technology to image RNA molecules with high accuracy and unrivaled detection efficiency at subcellular resolution. MERFISH provides transformative insight into a wide range of tissue-scale basic research and translational medicine in oncology, immunology, neuroscience, infectious disease, developmental biology, and regenerative medicine. For more information, go to www.vizgen.com
Position Summary:
Working closely with our Engineering and R&D teams and our CMO, the Instrument Manufacturing Engineer will be responsible for supporting instrument manufacturing and the implementation of operational improvements to support the commercialization of Vizgen’s MERFISH spatial transcriptomics technology. This Instrument Manufacturing Engineer will work to implement operational improvement to optimize quality, cost and on-time delivery (Lean Manufacturing) and ensure timely resolution of production improvements in support of Vizgen’s commercialization plans.
  • Work closely with engineering and R&D teams to develop and implement instrument QC processes, and analytical and functional tests, ensuring process robustness
  • Work closely with our Engineering team and CMO partner to implement both Design and Lean Manufacturing improvements to further instrument quality, cost and on-time delivery.
  • Address and manage all issues that arise at our manufacturing partners regarding build issues
  • Develop a spare parts stocking strategy and implement same for rapid resolution of customer instrument issues
  • Assist Field Service staff with escalated issues, instrument installs, repairs and failure analysis when necessary
  • Create methods to monitor and report progress on quality, cost and delivery of instruments
  • Support new product introduction activities
  • Support quality system compliance including material dispositions, change order implementation, and nonconforming evaluations.
Job Qualifications:
  • A bachelor’s or master’s degree in engineering, bioengineering, mechanical/chemical engineering or a closely related discipline and 5+ years of related manufacturing industry experience.
  • Experience streamlining workflows and developing robust manufacturing processes.
  • Experience working within regulated environments (FDA, IVD, LDT, ISO, etc.) is preferred.
  • Strong communication and collaborative skills, working with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
  • Experience with statistical data analysis, monitoring data quality, and troubleshooting technical problems is a plus
Vizgen affords equal employment opportunity to all qualified persons regardless of race, color, religious creed, national origin, age, military status, sexual orientation, disability, genetic information, gender identity, gender expression or gender unless based upon a bona fide occupational qualification.
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