Manufacturing Engineer IV (Staff

Biolinq Manufacturing Engineer

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.

Job Purpose:

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

Duties and Responsibilities:

• 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 supply chain.
• Transfer peripheral processes and subassemblies to contract manufacturing sites.
• Manage manufacturing activities and project execution with external vendors.
• Support communication, collaboration, and strategic relationship with key suppliers.
• Develop business processes, infrastructure, and tools to improve manufacturing execution.

Requirements:

Qualifications:

• BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline…