ShifaMed-posted 3 months ago
$56,000 - $67,000/Yr
Full-time
Los Gatos, CA
Securities, Commodity Contracts, and Other Financial Investments and Related Activities

This position is responsible for the manufacturing and preparation of assemblies for operations and R&D medical devices. May develop into more complex manufacturing processes such as bonding and electrical soldering and assembly processes. Part of a small manufacturing and R&D team with daily interactions with engineers and technicians. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.

  • Apply adhesives to small components using needles, EFD dispensers, and syringes.
  • Utilizes various techniques for bonding different materials with heat, lamination, UV cure processes.
  • Perform manufacturing processes and inspections under a microscope.
  • Solders small parts and wires to printed circuit boards and completes re-work.
  • Follow Manufacturing Process Instructions (MPIs) to build and inspect medical devices. Fill out design history files (DHR) as required.
  • Work on several different batches at different manufacturing processes throughout the day.
  • Communicate and document issues and observations with supervisor and engineers.
  • Comply with production control requirements including those related to environmental controls, CER requirements, hygiene, documentation, and procedural compliance.
  • Support the Quality System and Quality Policy. Be aware of Quality System procedures, requirements, and training requirements. Inform responsible personnel of concerns involving product quality.
  • Ability to read and interpret bill of materials (BOM) and accurately pick materials required for scheduled work orders.
  • Reviews work orders and ensure appropriate level of materials, tools, equipment, and resources are available for production functions.
  • Completes in-process-inspection to ensure product meets work instruction specifications, quality attributes and reports variances immediately to lead/supervisor.
  • Responsible for assigned production efficiency, productivity and accuracy of items produced to minimize backlog. Meets or exceeds standard rates.
  • Maintains the cleanliness, organization, quality control and safety of work area.
  • Follows safe working practices and wears required personal protective equipment.
  • Mechanical aptitude and skills using hand tools, small power tools and soldering iron.
  • Ability to read and interpret schematics, prints and engineering documentation.
  • Skill in performing basic mathematical calculations.
  • Ability to distinguish colors for color coding practices.
  • Ability to perform detailed repetitive tasks for prolonged periods of time.
  • Attentive to detail with good planning time management skills, and willing to assume a variety of production/assembly related tasks.
  • Skills in effectively listening and communicating tactfully verbally and in writing.
  • Ability to establish and maintain effective working relationships internally and externally.
  • Fine dexterity for assembling small components and good attention to detail.
  • Good understanding of GMP, Clean room procedures and behavior.
  • Ability to use tools and measurement devices. Ability to use automated equipment.
  • Good communication skills to describe issues or observations as they are observed.
  • Must be able to document activities clearly. Basic computer and writing skills. Must be a team player.
  • High School Diploma or General Education Development (GED) certificate.
  • Experience in a manufacturing/assembly work-related environment required.
  • HS diploma (AA degree preferred) or equivalent experience in technical discipline and a minimum of 5 years (3 with AA) in medical device manufacturing.
  • Experience with 5S manufacturing.
  • Experience with medical device manufacturing including following good manufacturing practice (GDP).
  • Base salary range for this full-time position is between $56,000 to $67,000 + equity + benefits.
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