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Senior Manufacturing Technician

Senior Manufacturing Technician

Fluxus Inc.Sunnyvale, CA, US
30+ days ago
Job type
  • Full-time
Job description

The individual will be “hands-on” working closely with operations to support product, process and manufacturing. Activities will consist, but will not be limited to product prototyping, fixturing design and fabrication, process improvements, inspection and test, production assembly, writing protocols and reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be

assigned as necessary)

  • Will be responsible for assembly of Optofluidic Cartridges, Electro-Mechanical Equipment
  • Establishment of process flow and production line layouts
  • Design, support and Implementation of manufacturing fixtures
  • Perform process validations (IQ / OQ / PQ)
  • Write Manufacturing Procedures, protocols and test reports
  • Perform routine Preventive Maintenance
  • Ability to work in a fast-paced dynamic environment

QUALIFICATIONS :

  • Hands-on individual with demonstrated experience in Medical Device / IVD manufacturing
  • Experience utilizing Solidworks preferred
  • Ability to solve problems using structured methods.
  • Attention to detail in process characterization and documentation.
  • Ability to work in a team environment
  • Have a firm understanding and demonstrated experience conducting medical device process validations.
  • Firm understanding of manufacturing techniques with ability to improve line capacities and to develop high volume manufacturing scale-ups.
  • Statistical Process Control, Green Belt experience preferred
  • Fluent using Word and Excel.
  • Good written and verbal communication skills
  • Machining skills preferred

    • EDUCATION and / or EXPERIENCE

  • High School Diploma or equivalent
  • Minimum 5 years of medical device manufacturing experience is preferred
  • Able to interpret technical drawings and specifications.
  • Good knowledge of cGMP.
  • Ability to work in a fast-paced environment.
  • Ability to multi-task and interact well with others.

    • ABOUT FLUXUS

    Fluxus is a leader in optofluidics that provides systems and solutions to advance the detection, diagnosis, monitoring, and treatment of disease. Our expertise lies in the interface of advanced photonics, MEMS, engineering, assay development, and reagent manufacturing excellence.

    We seek to close a major gap in clinical research and diagnostics by bringing our groundbreaking ultrasensitive detection technologies and assay solutions to researchers, clinicians, patients, and key industry players through strong partnerships and a future-proof portfolio of innovative products.

    Fluxus was founded in and acquired in by Fujirebio Holdings, Inc., an R&D-driven company developing novel IVD technologies and biomarkers with high clinical value.

    Today, as a wholly owned subsidiary of Fujirebio, Fluxus represents a unique blend of Silicon Valley startup ingenuity with the stability and reach of an established multinational corporation. Our experienced, multidisciplinary team draws on deep and varied expertise to continuously innovate and drive towards our goal of becoming the gold standard in single molecule counting and ultrasensitive biomolecular testing.