Manufacturing Assembly Specialist

2 weeks ago

Baltimore, Maryland, United States Novel Microdevices Inc. Full time
Position Overview

Novel Microdevices Inc. is in search of a Manufacturing Assembly Specialist to contribute to the production of components for an innovative medical device. The selected individual will work under close supervision to produce, clean, and assemble plastic components in accordance with established assembly protocols, while also engaging in various laboratory tasks and maintenance duties.

Key Responsibilities

The Manufacturing Assembly Specialist will be responsible for:

  • Adhering to documentation procedures, including completing Data History Records (DHRs) and interpreting instructions from Work Release (WR), Planned Deviation Report (PDR), or Non-Conformance Report (NCR). Understanding and following Standard Operating Procedures (SOPs) and Manufacturing Work Instructions.
  • Upholding standards for dry room and cleanroom environments, ensuring practices and housekeeping align with standard operating procedures.
  • Utilizing proper techniques to cut and clean plastic components to ensure compatibility with biological samples.
  • Assembling multi-layered parts in a meticulous manner within a controlled environment.
  • Conducting inspections (both visual and using specialized tools) of raw materials and finished products, as well as performing in-process checks to confirm quality compliance.
  • Carrying out additional tasks as assigned, which may include laboratory upkeep, record maintenance, inventory packing, and storage.
  • Comprehending and adhering to safety regulations and practices.
  • Maintaining and cleaning equipment and workspaces as necessary.
  • Employing tools such as microscopes, tweezers, and other hand-held instruments.
  • Identifying minor equipment issues and associated documentation discrepancies, taking appropriate corrective actions, and promptly notifying Supervisors and Leads of any concerns.
Essential Qualifications

The ideal candidate will possess:

  • Experience in cleanroom assembly or manufacturing within the medical device, pharmaceutical, or biotechnology sectors, or a comparable combination of education and experience.
  • Strong manual dexterity and proficiency in hands-on tasks.
  • A keen attention to detail.
  • Effective communication skills, both verbal and written.
  • Competence in Microsoft Word and Excel.
  • The ability to solve basic mathematical problems.
Preferred Qualifications

Additional desirable skills include:

  • Experience in a clean and regulated environment related to medical device assembly.
Educational Background

A minimum of an Associate's degree in engineering or a related field, accompanied by at least 2 years of relevant experience is required.

Physical Requirements

Candidates must be able to:

  • Lift up to 25 lbs and stand for extended periods.
  • Engage in repetitive arm and wrist movements.
  • Work directly with, handle, or come into contact with chemicals or reagents.
Travel Requirements

No travel is required for this position.

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