Assembly Technician

About You: In this technical production role, you will be responsible for the assembly of instrument and consumable components for the VitalOne System. The primary focus will be on the assembly of prototype and final product assemblies for use in testing, validation and verification as well as final product manufacturing. Working directly with all supporting functions, this role will apply defined processes through , work instructions, batch records, manufacturing aids and create assembly, inspection, and test records of batches and units built.

Duties include, but are not limited to, setup and building of instrument or consumable assemblies, using manual and semi-automated equipment, preparation of materials for assembly, maintaining a safe and organized work environment; performing inspections and/or testing on sub-assemblies and samples and recording results; as well as monitoring inventory levels and performing system transactions for the tracking and issuance of production materials. Assemble instrument and consumable assemblies 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 units as well as initiating non-conformance reports where needed; Set up, operate, and monitor automated and semi-automated equipment used in the assembly process; Use microscopes, torque tools, fixtures and measurement devices to complete assembly steps accurately; Collaborate in the development, setup, and maintenance of cGMP processes as we transition from prototype assembly processes to production-scale 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. High school diploma; 3+ years of industry experience in medical device or electronic assembly, preferably in a cGMP environment; Excellent manual dexterity and visual acuity; Ability to read, understand and follow written assembly and test instructions and maintain high levels of accuracy 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.

Bonus points for: Experience working with reagents and use of pipettes and liquid measuring equipment Experience with optical alignments, microfluidics or sensor based instruments Experience with 5s, kanbans, and lean manufacturing processes; Prior experience with single-use cartridge assembly, reagent fill and seal, or complex instrument assembly would be welcomed; An appreciation of puns!