About the CompanyBiolinq 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 PurposeResponsible for activities and area goals through qualification, deployment, and sustaining at the component and finished product level.Duties and ResponsibilitiesSupport 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.QualificationsBS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline requiredMinimum 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 toolsStrong understanding of process interactions (inputs, outputs) that are both technical and system relatedExpertise with scaling manufacturing processes to commercial volumesExperience with budgeting, cost management, modeling, and preparing business proposals (ROI, NPV) for new initiatives seeking executive approvalStrong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standardsExperience 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)Strong leadership skills, including the ability to set goals, allocate resources to appropriate priorities, and provide constructive feedback to foster positive relationshipsProficiency in Microsoft Office toolsProficiency with JMP, Minitab, or equivalent statistical softwareExperience with ERP, MES, and other manufacturing systemsProficiency in BMRAM or equivalent asset management systemExpertise in several specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packagingProficiency in Solidworks or equivalent CAD software (preferred)Experience with MS Project, Visio, and other project management tools (preferred)Experience with manufacturing database, controls, and vision (preferred)Experience with Altium or other electronics design software (preferred)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 decisionsExcels at identifying solutions to accelerate team's learning of the problem spaceStrong organizational planning and ability to hold others accountable. Breaks down silos within and across teams to ensure forward progress and collective successAbility to take decisive action and deliver tangible results in a cross-functional organization. Leadership aptitude of teams, projects, and programsWorking ConditionsGeneral Office, Laboratory, and Cleanroom environmentsExpected travel less than 10%Physical RequirementsWhile performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.BenefitsMedical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.Equal Employment OpportunityAt Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke-free workplace.As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $125,000 to $140,000. We may ultimately pay more or less than the posted range. Actual compensation packages are based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at Careers@biolinq.comSalary$125,000-$140,000 per year#J-18808-Ljbffr