Senior Manufacturing Engineer

Description

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The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers . While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.

About the Company

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

• •BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required
• •Minimum 5-8 years related experience, including years of higher-level education (MS, PhD)
• •Experience in design of experiments and statistical tools (ANOVA, t-test, etc.)
• •Experience with Fishbone, A3, 5Y, and other root cause investigation tools
• •Experience in high-volume manufacturing operations within medical device, electronics, or biotechnology industries
• •General understanding of system interactions and interdependencies between processes
• •Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards
• •Experience with lean manufacturing and six sigma methodologies (preferred)
• •Experience with design for manufacturability concepts and product development lifecycle (preferred)
• •Experience with standard electrical, mechanical, and wet lab test equipment (preferred)
• •Proficiency in developing and delivering technical and executive-level presentations. Promotes alignment, action, and accountability framework within working teams
• •Proficiency in Microsoft Office tools
• •Proficiency with JMP, Minitab, or equivalent statistical software
• •Experience with ERP, MES, and other manufacturing systems
• •Proficiency in BMRAM or equivalent asset management system
• •Expertise in one or more specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packaging
• •Proficiency in Solidworks or equivalent CAD software (preferred)
• •Experience with MS Project, Visio, and other project management tools (preferred)
• •Fosters a positive and inclusive work environment. Engages in productive conflict with thoughtful questioning
• •Proactively identifies roadblocks and implements mitigations to minimize disruptions. Builds more efficient processes and finds better ways
• •Sustained reliability, transparency, and integrity. Strong resiliency when faced with challenges
• •Ability to come up to speed quickly, navigate uncertainty, and make timely decisions. Ability to condense complex requirements into specific and measurable objectives
• •Strong quality-orientation with attention to detail and a desire to del