About You: In this technical production role, the Assembly Technician II will be responsible for supporting the production scale up of processes for assembly of instruments, modules and sub-assemblies for the VitalOne System. A primary focus will be on building and testing prototype instruments for use by the engineering and science teams to test and refine designs along with assisting in the development of assembly and testing processes as we transition into commercial production. Working directly with the manufacturing engineering team, this role will help to improve assembly and inspection processes, define work instructions, identify, and develop fixtures as well as record assembly, inspection and test data of batches built.

Duties include, but are not limited to, setup and build of electro-mechanical assemblies and instruments; preparation of equipment and materials for assembly; performing inspections and/or testing on assemblies and recording results; as well as monitoring inventory levels and performing system transactions for the tracking and issuance of production materials. Assemble electro-mechanical modules, subassemblies and finished instruments from draft work instructions with high quality and consistency for use in prototype testing along with verification and validation testing. Perform incoming, in-process and final inspection and test of assemblies, creating records for completed units as well as initiating non-conformance reports where needed Build prototype assemblies and provide DFx input to engineering teams as well as assist in creating draft work instructions and rework instructions Provide recommendations to the manufacturing engineers for improvements to manufacturing work instructions, assembly and test fixtures and processes.

Collaborate with Manufacturing Engineering and Design Engineering in the development of new processes and work instructions. Assist in establishing point of use inventory and setting up production stations for assembly of new products and sub-assemblies. Implement 5s and lean principles to maintain organization and good housekeeping practices in the manufacturing area Perform troubleshooting and initial root cause analysis to isolate defects occurring during the manufacturing process and collaboratively work with Mfg Engrg and or Design Engineers to determine and resolve root causes.

Participate in the development of processes to support establishment of cGMP throughout manufacturing. Work with Engineering, Systems and Manufacturing Engineering 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 Train new employees in specific manufacturing processes and procedures and confirm their competency based on observation. Support and participate in root cause investigations for Non-conformances, deviations and CAPA actions related to manufactured product and manufacturing processes. Associate or Bachelor’s Degree in STEM; 2-5 years of industry experience in medical device or electronic assembly, preferably in a cGMP environment Experience working with software driven equipment; Excellent communication skills and attention to details; Strong organizational skills and ability to multitask across projects and activities; Proven ability to collaborate cross-functionally and participate on multi-disciplinary teams.

Bonus points for: Experience with 5s, kanbans and lean manufacturing processes; Prior experience with complex electro-mechanical systems troubleshooting and repair An appreciation of puns!