Assembly Technician

Posted 3 months ago

POSITION TITLE: Assembly Technician 

LOCATION: Baltimore, MD

POSITION SUMMARY:

Novel Microdevices is seeking a skilled Assembly Technician to assist us as we shift from product development to product manufacturing.  The ideal candidate will possess the attention to detail and flexibility to assemble testing components in a rapidly changing environment.  The assembly technician will work closely with the engineering team to provide feedback on improvements to the assembly process as we move from low volume production for testing to high volume production for clinical trials.  

PRIMARY DUTIES:

  • Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions
  • Maintain dry room and cleanroom standards, practices, and housekeeping according to standard operating procedures.
  • Prepare plastic sheets to be cut in a Laser cutter
  • Cut and clean plastic parts using proper technique to support biological sample contact
  • Inspect (visual and using inspection tools) raw materials and well as finished products. Perform in-process inspection of components and assemblies to verify quality conformance
  • Accurately and repeatedly assemble components (in a clean environment) from delicate parts based on plans provided 
  • Perform other duties as assigned such as laboratory maintenance, record keeping, packing, and storing inventory, etc.
  • Understand and adhere to safety policies and practices
  • Clean and maintain equipment and work area as needed
  • Use microscopes, tweezers, and other hand-held tools
  • Recognize any minor issues from the equipment and any affiliated documentations and take appropriate corrective action within scope.  Notify Supervisors and Leads of issues and discrepancies immediately
  • Adhere to quality guidelines

REQUIRED SKILLS: 

  • Experience in clean room assembly or manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience
  • Understands Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
  • Ability to read drawings
  • Strong working skills with your hands
  • Flexibility to adapt to rapidly changing procedures 
  • Attention to detail
  • Communicate effectively both orally and in writing
  • Competency with computers and related software applications (Laser Cutter software for CAD/CAM, Word, and Excel)
  • Ability to solve basic math problems

DESIRED SKILLS:

  • Prior experience working with machine shop tools like CNC mill and LASER Cutter
  • Experience working in a clean and regulated setting related to medical device assembly
  • Previous experience as a team lead in a manufacturing setting is a plus

EDUCATION:

  • Associate degree in engineering or related with 2+ years of relevant experience

PHYSICAL ABILITY:

  • Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions
  • Ability to work directly with, handle, or come into contact with chemicals or reagents

TRAVEL REQUIREMENTS:

None

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