Senior Assembly Technician

About You: In this senior technical production role, you will be responsible for helping to drive the production scale up of processes for module and instrument assemblies for the VitalOne System. Your primary focus will be to bridge between Mfg Engrg and the assembly team to develop, transfer and improve the processes for assembly and testing of prototype modules and instruments for use by the engineering and science teams to test and refine designs. In addition, you will be a production SME, providing DFx input and collaborating with instrument manufacturing leadership and manufacturing engineers to develop and implement good manufacturing practices as part of commercial scale up.

Working directly with the manufacturing engineering team, this role will help to create and improve assembly and inspection processes, define work instructions, identify, and develop fixtures as well as investigate, troubleshoot and resolve production issues. Duties include, but are not limited to, setup, build and test of electro-mechanical assemblies and finished instruments; preparation and setup of equipment and materials for assembly; test sub-assemblies, components and assemblies and record results; perform root cause analysis of manufacturing defects as well as monitoring inventory levels and performing system transactions for the tracking and issuance of production materials. Become the Subject Matter Expert in one or more of the critical assembly processes - determining process capability, driving improvements in the process as well as leading investigations and troubleshooting to resolve issues and non-conformances Assemble electro-mechanical sub-assemblies, modules and instruments with high quality and consistency for use in prototype testing along with verification and validation testing.

Implement setup and line clearance processes and instructions for instrument assembly including the appropriate record keeping to operate under cGMP Use complex equipment and SW driven tools as well as hand tools to execute assembly and test processes. Perform advanced troubleshooting of in-process and testing failures to determine and address root causes and generate root cause analysis reports. Decontaminate and repair modules, sub-assemblies and instruments returned from Engineering or Customers and generate repair and refurbishment records.

Provide feedback and recommendations to the manufacturing engineers for improvements to manufacturing work instructions, assembly and test fixtures and processes. Drive 5s and lean activities to improve the manufacturing processes and overall production efficiency. 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 Collaborate with Quality in performing root cause investigations for Non-Conformances, Deviations and CAPA actions related to manufactured product Train manufacturing team members on specific technical processes to build workforce flexibility and capability in production.