Medical Device Assembly Specialist

6 hours ago

Mississauga, Ontario, Canada Vitalbio Full time

Vitalbio is a leading medical diagnostics company driving innovation in global healthcare. We're seeking an experienced Medical Device Assembly Specialist to join our team and contribute to shaping the future of medical diagnostics.

Job Summary:

We offer a competitive salary of $65,000 - $80,000 per year, depending on experience.

The Medical Device Assembly Specialist will be responsible for the assembly of consumable components and kits for the VitalOne System. This technical production role requires a strong focus on quality and attention to detail.

About You:

  • High school diploma or equivalent required;
  • 3+ years of industry experience in medical device or electronic assembly, preferably in a cGMP environment;
  • Experience working with reagents and use of pipettes and liquid measuring equipment;
  • Excellent communication skills and ability to work collaboratively in a team environment;
  • Strong organizational skills and ability to multitask across projects and activities.

Key Responsibilities:

  • Assemble consumable microfluidic cartridges, fill and seal reagent packs, and finished consumable kits with high quality and consistency for use in prototype testing as well as formal verification and validation testing;
  • Perform in-process and final inspection and test of assemblies, creating records for completed batches as well as initiating non-conformance reports where needed;
  • Set up, operate, and monitor automated equipment to transition to automated assembly of cartridges and reagent packs;
  • Collaborate in the development, setup, and maintenance of cGMP processes as we transition from prototype assembly processes to production-scale automated processes;
  • Provide feedback and recommendations to the manufacturing engineers for improvements to manufacturing work instructions, assembly, and test fixtures and processes;
  • Maintain accurate records of production, including taking inventory of production and prototype materials through cycle counting and physical inventories;
  • Apply 5s and lean principles to maintain organization and good housekeeping practices in the manufacturing area;
  • Work with Engineering and Assay Development teams to incorporate improvements into the manufacturing process based on testing results and observations;
  • Participate in process FMEAs and risk identification as well as assisting with the implementation of appropriate countermeasures;
  • Assist Manufacturing Engineering in the setup and validation of new equipment for use in the assembly process;
  • Execute daily, weekly, and monthly preventive maintenance and cleaning activities of equipment and manufacturing areas;
  • Support and participate in root cause investigations for, Out-of-Specification (OOS) investigations, Quality Incident Notifications, and CAPA actions related to manufactured products and manufacturing processes;

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