About you:

In this technical production role, you will be responsible for the assembly of consumable components and kits for the VitalOne System. The primary focus will be on the assembly of prototype consumables for use by the engineering and science teams for testing and refining the designs.  Working directly with the manufacturing engineering team, this role will help identify fixture needs as well as provide feedback on assembly and inspection processes, work instructions, and fixtures as well as create assembly, inspection, and test records of batches built. Duties include, but are not limited to, setup and building of consumable assemblies, using manual and semi-automated equipment, preparation of materials for assembly, including laser cutting and cleaning materials using ultrasonic baths,  maintaining a safe and organized work environment; performing inspections and/or testing on samples of consumable assemblies and recording results; as well as monitoring inventory levels and performing system transactions for the tracking and issuance of production materials. 

What you’ll do:

• 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;

What you need:

• High school diploma;

• 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 attention to detail;

• Strong organizational skills and ability to multitask across projects and activities;

• Proven ability to collaborate cross-functionally and participate in multi-disciplinary teams.

What you’ll get:

• An opportunity to shape the future of medical diagnostics and make a meaningful impact on global healthcare;

• A collaborative environment with a high-performing team dedicated to innovation and excellence;

• Competitive compensation and benefits package;

• A platform to showcase your talents and grow professionally in a company that values your contributions.

What excites us:

• Experience with 5s, kanbans, and lean manufacturing processes;

• Prior experience with single-use cartridge assembly, reagent fill and seal, and lyophilization processes would be welcomed;

• An appreciation of puns!