Biolinq · 4 months ago
Manufacturing Engineer IV (Staff)
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $140K/yr
8+ years expBiolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of clinical conditions. The Manufacturing Engineer IV will be responsible for supporting production monitoring, maintaining equipment documentation, and optimizing manufacturing processes to ensure quality and efficiency.
BiotechnologyHealth CareMedical DeviceWearables
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
Qualification
Required
BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required
Minimum 8-12 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
Strong understanding of process interactions (inputs, outputs) that are both technical and system related
Expertise with scaling manufacturing processes to commercial volumes
Experience with budgeting, cost management, modeling, and preparing business proposals (ROI, NPV) for new initiatives seeking executive approval
Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards
Strong leadership skills, including the ability to set goals, allocate resources to appropriate priorities, and provide constructive feedback to foster positive relationships
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 several specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packaging
Ability to take decisive action and deliver tangible results in a cross-functional organization. Leadership aptitude of teams, projects, and programs
Preferred
Experience with lean manufacturing and six sigma methodologies
Experience with design for manufacturability concepts and product development lifecycle
Experience with standard electrical, mechanical, and wet lab test equipment
Proficiency in Solidworks or equivalent CAD software
Experience with MS Project, Visio, and other project management tools
Experience with manufacturing database, controls, and vision
Experience with Altium or other electronics design software
Role model for what kindness looks like. Actively levels up those on the team through example setting, guidance, and support. Empowers others to make effective decisions
Excels at identifying solutions to accelerate team's learning of the problem space
Strong organizational planning and ability to hold others accountable. Breaks down silos within and across teams to ensure forward progress and collective success
Benefits
Medical
Dental
Vision
Health savings account
Flexible spending account
Life and long-term disability insurance
401(k) plan
Holidays
PTO
Company
Biolinq
Biolinq develops a wearable biosensor platform that is capable of measuring blood level information.
51-200 employees
H1B Sponsorship
Biolinq has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$276.3MKey Investors
Alpha Wave VenturesRiverVestM Ventures
2025-03-19Series C· $100M
2024-04-04Series Unknown· $58M
2021-11-02Series B· $100M
Leadership Team
Rich Yang
CEO
Jared Tangney
Co-Founder, President & CTO
Recent News
2025-12-24
Crunchbase News
2025-10-20
Company data provided by crunchbase