Senior Manufacturing Engineer

Biolinq Incorporated•San Diego, CA

2d•$110,000 - $125,000•Onsite

About The Position

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.

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
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
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 deliver service excellence. Bias for action, acts with urgency to deliver work that adds value

Nice To Haves

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 Solidworks or equivalent CAD software (preferred)
Experience with MS Project, Visio, and other project management tools (preferred)

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