Medical Device Assembler

Mykelly

Town of Skaneateles (NY)

On-site

USD 57,308,000 - 63,039,000

Full time

3 days ago
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Job summary

Mykelly is seeking a Medical Device Assembler in Skaneateles, NY on 1st, 2nd and weekend shifts. You will assemble and test medical devices per procedures, use hand tools, power tools, and automated equipment, and document production activities.

This full-time role requires adherence to GMP and FDA standards, packaging components, maintaining inventory, and contributing to lean initiatives while maintaining a clean, safe workspace.

Qualifications

  • Experience assembling and testing medical devices.
  • Familiarity with GMP and FDA regulations.
  • Document production activities in device history records.

Responsibilities

  • Assemble and test medical devices per procedures.
  • Use hand tools, automated machinery and power tools per GMP/FDA.
  • Prepare and verify component kits for assembly lines.
  • Handle materials and inventory; report discrepancies.
  • Follow SOPs and quality standards; escalate issues as needed.
  • Participate in lean manufacturing initiatives.
  • Package and label parts for shipment or storage.
  • Maintain a clean, safe workspace and report hazards.

Skills

Hand tools
Power tools
Automated machinery
Attention to detail
Documentation

Tools

Hand tools
Automated machinery
Power tools

Job description

Job Title: Medical Device Assembler

Compensation:

  • 1st Shift: 6:30am-3:00pm - $20.00/hr
  • 2nd Shift: 2:55pm-11:25pm - $21.40/hr
  • Weekend Plus: Sat/Sun 6am-6pm + Mon/Tue 6:30am-3:00pm - $22.00/hr
  • Weekend: Sat/Sun 2:55pm-11:25pm - $21.40/hr

Location: Skaneateles, NY

Essential Duties and Responsibilities:
  • Assembly Operations:

    • Assemble and test medical devices, equipment, and components per established procedures and quality standards.
    • Utilize hand tools, automated machinery, and power tools, complying with GMP and FDA regulations.
    • Assemble electronic components and modules per schematics and diagrams.
    • Complete Device History Record paperwork, documenting production activities.
  • Kit Preparation:

    • Organize kits with necessary components; verify accuracy and completeness as per work instructions.
    • Maintain and replenish inventory levels; label and package kits for assembly lines or other departments.
  • Production Support:

    • Handle materials and assemblies, ensuring proper storage and inventory maintenance.
    • Report discrepancies or quality issues to Team Leaders.
  • Quality Control:

    • Escalate quality issues, defects, or non-conformities as required.
    • Follow SOPs and work instructions; ensure compliance with regulatory requirements and internal standards.
  • Continuous Improvement:

    • Complete required training and certifications.
    • Participate in lean manufacturing initiatives.
  • Packaging:

    • Package and label component parts or assemblies; prepare items for shipment or storage.
  • Safety Compliance:

    • Comply with EHS requirements, safe work practices, and company policies.
    • Maintain a clean, organized workspace and report hazards or incidents promptly.
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