Manufacturing Engineer IV (Staff)
Manufacturing Engineer IV (Staff)
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USD 125000 - 140000
1 Vacancy
Job Description
WARNING about fake job posting scams. There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles Under the guise of asking you to fill out an application the scammers are attempting to gather your personal information. See the Federal Trade Commissions warning on this topic at: only official source for actual Biolinq job postings/openings is at While other job sites (such as LinkedIn Indeed or Glassdoor) may pull from Biolinqs careers web page you should visit 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.
Qualifications
- 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
- 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)
- 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
- Proficiency 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 decisions
- Excels at identifying solutions to accelerate teams 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
- Ability to take decisive action and deliver tangible results in a cross-functional organization. Leadership aptitude of teams projects and programs
Working Conditions
General Office Laboratory and Cleanroom environments
Expected travel less than 10%
Physical Requirements
While 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.
BENEFITS
Medical dental vision health savings account flexible spending account life and long-term disability insurance 401(k) plan holidays and PTO.
At 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 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: $125000 to $140000. 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.
Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may at its discretion assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. 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
Employment Type
Full-Time
