Senior Manufacturing Engineer

Description

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Responsible for activities and area goals through qualification, deployment, and sustaining at the component and finished product level;

• Support production monitoring with in-process test execution and trending;
• Define appropriate alert and action limits based on process performance;
• Maintain effectiveness of manual test methods through training and certification process;
• Assess equipment and process for ergonomics and safety;
• Partner with appropriate vendors to design tooling for production fixturing;
• Identify system-process interactions using standard tools (p-diagram, SIPOC, VSM);
• Design or modify existing equipment and fixtures for usability and robustness in manufacturing;
• Maintain equipment related documentation (manuals, drawings, specifications);
• Complete line replication and re-qualification activities to support demand, including at key suppliers;
• Maintain risk documentation (PFMEA) for new failure modes and mitigations;
• Coordinate with Planning to manage build schedule and material allocation per demand;
• Provide guidance and training to operators on engineering and V&V builds, as needed;
• Confirm team comprehension of builds requests, redlines, and special instructions;
• Develop sustaining cost model for lab supplies, consumables, fixtures, and spare parts;
• Collect time measurements and process videos to baseline headcount needs;
• Provide voice of manufacturing to ensure successful transfer from R&D to production;
• Remediate build documentation for clarity and standardization;
• Develop hands-on training materials for critical processes and equipment (pipetting, etc.);
• Develop job aids and other guidance documents to support process adherence;
• Provide technical training to operators for assigned equipment and processes;
• Identify and implement mistake-proofing opportunities;
• Participate in daily meetings to review build plan, metrics, and escalations needing support;
• Complete standard work activities to monitor production status and identify gaps;
• Complete periodic work (equipment setup, test verification, etc.) to support build plan;
• Maintain equipment status (preventative maintenance, corrective maintenance, spare parts) to minimize line disruption (OEE);
  Revise schedule and activities as appropriate based on history and risk;
• Monitor and replenish inventory levels of production materials, fixtures, and supplies;
• Submit purchase requisitions for items required by manufacturing and engineering projects;
• Support 5S adherence in manufacturing by completing routine audits and identified actions;
• Resolve technical or logistics issues impacting build delivery;
• Complete root cause investigation and actions for non-conformances (NCMR, CAPA, SCAR);
• Monitor production performance through control charting, reject pareto, and review of process capability (SPC);
• Maintain up-to-date model data (manual time, auto time, cost) for assigned processes;
• Share performance trends, insights, and strategic insights with cross-functional team for alignment;
• Develop data collection and integration processes for visibility to production status;
• Support facility expansion, site transfer, and capacity planning activities;
• Optimize processes for quality, efficiency, and process repeatability at the lowest cost;
• Complete standardized work and line balancing activities to optimize production output;
• Utilize problem solving techniques to identify root causes to technical issues (rejects, equipment availability, etc.) and implement sustainable countermeasures to address them;
• Investigate device observations and field complaints related to manufacturing process;
• Collaborate with R&D, Supply Chain, and Quality to drive actions, priorities, and trade-offs required to meet targeted COGS;
• Complete change impact assessment to align implementation plan for proposed changes;
• Evaluate and implement 2nd source vendors for manufacturing supply risk;
• Define appropriate lot size and packaging format for raw materials to scale with demand;
• Integrate external and internal processes to optimize end-to-end…