Daniel Zeilermeir

Experience

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  Dotronix Inc

  Jun 1990 - Sept 2000

  Calibration, Engineering, and Facilities Maintenance Technician

  * Created, implemented, and maintained equipment calibration for New Brighton, MN and Eau Claire, WI manufacturing sites* Supported Production, Engineering, and Facility maintenance needs* Lead Floor technician for Engineering (Applications) NPI transition to production* Support product builds, modifications, ECOs, TCOs, and janitorial as needed* Worked in creation and the maintaining of all production and facility equipment maintenance

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  Celestica

  Sept 2000 - Dec 2003

  Operations Engineering Support Technician

  •Procure NPI inventories, create ERP product family, maintain and create second/setup source vendors•Perform and modify production test machines and modules with upgrades•Troubleshooting to the component level with failure analysis and trends•Coordinate Change Orders (engineering and production)•Focus on Critical Product for engineering, new product designs, test coverage, development, troubleshooting for product turn-around times, documentation, and a standards focus on record keeping and feedback.•GMP, 5S, World Class, Lean, 6 Sigma, and Clean-room Manufacturing Training and Certification •Continuous improvement, documentation project control regarding FDA and ISO requirements•Point person for customer product returns (failure and root cause analysis) Show less

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  St. Jude Medical (now Abbott)

  Dec 2003 - Dec 2016

  Built production self-sustaining team for tissue heart valves with >90% yield.Key team member in setting up and transferring product line from Minnesota to Brazil.Documentation and validation activities in relation to manufacturing processes, FDA adherence, specifications, procedures, continuous improvement, process optimization, and variation reduction. Personal GDP saved over $120,000 in product recall saving 6 months of product not being recalled.Proven track record takes place in a harsh high-speed every-changing environment where at times was difficult to raise issues. “Talent Team” member (1 of 2 people) for specific product line readiness task including 5S, TACT Time, bottlenecks, and process flow optimization. Managed budget around 2 Million for new process and equipment with in-sourcing and outsourcing development and CAPEX.Specific HMI/GUI program design, development (w/Automation Experts) consisting of a multiple step recipe process control consisting of many input and control variables producing a quality record printout upon recipe cycle completion. CAPA project updated a process where the operator had visible indication showing exposure time expiration. A program change where the whole screen illuminated green until time was close, then the screen blinked yellow, and when time was critical, the screen would blink red. The screen would then go black if exposure time or temp threshold was exceeded preventing process close out. •Operational Excellence (ME): Apply Lean and Six Sigma with optimization fundamentals •Product/Process Development (PD): Machine & fixture design, DOE experience, V&V•Successfully designed a die to address project critical field-failure potential issue•Experience: Over twenty-four years working in the medical device field•Support ISO 14001 Environmental and MN EPA company directive Show less •Writing and performing qualifications including the SRS, Software Validation, Equipment and process IQ/OQ/PQ/MP/IP/TMV/FMEA work and training, while supporting and releasing documentation per internal and external guidelines•20+ Years experience in the medical device and related fields•Key input provider for capital project and resource allocation•Develop, write, and train for new manufacturing, inspection, monitoring, testing, and preventative maintenance procedures•Successfully implemented vacuum drying equipment with process time reduction from 24 hours to 8 hours (core team equipment owner)•Data analysis on process tests for process capability and yield•Construct databases with product lines and all MVP related information•Write, update, and execute Quality Plans, Drawings, Specifications, Design Reviews, Qualification (protocols & reports) including environmental monitoring (Temp, RH, T-dew, %hg)•Daily facility, production, and engineering support with root cause analysis, problem solving, lean manufacturing, continuous improvement, and all applications in regard to FDA and ISO regulations•Design, modify, improve, and support current and new products and Process Development equipment (software/hardware) with appropriate documentation•Core Team member for ISO14001 writing and implementing related policies and procedures for ISO and EPA requirements•Design/Construct project management priorities and project time line with metrics•Continually monitor related activities for future issues and complication in down time prevention•Perform failure analysis on field return devices and destructive testing failures for trends and batch related issues•Advanced CAPA and NCMR knowledge, understanding, and change implementation Show less •Support all production maintenance needs (priority is keeping production up an running)•Proactive in production needs and machine setup criteria•Perform custom equipment maintenance and support•Write and improve maintenance procedures•Engineering project support, problem solving, and lean manufacturing applications, write and execute test plans, protocols/reports, with continuous regard to FDA and ISO regulations•Documentation expert for most documentation and process composition improvements•Support engineering on off shifts and with DOE testing and qualification Show less

  • Technician Sr., Mfg. Production Admin.

    Mar 2013 - Dec 2016

  • Manufacturing Technician I & II

    Jul 2005 - Mar 2013

  • Electro Mechanical Technician

    Dec 2003 - Jul 2005
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  LISI Medical Remmele

  Dec 2016 - Aug 2018

  Coordinate, administer, and escalate the implementation of company specific 'Excellence Achievement' initiatives (Lean Manufacturing) throughout the Minnesota facilities. Output success has been aligning Key team member where implemented LEAN meetings drove OTD to >90% in 45 daysLean manufacturing, business goals, business communications, cascading implementation workshops, and the training of company-wide staff to corporate proprietary Lean and CI standards.Training all levels of staff (Operations, Maintenance, Shipping & Receiving, Quality, Engineering, Supply Chain, Management, and HR) to the culture and methodologies for Continuous Improvement. Show less Manufacturing engineering:• Documentation supporting (GDP) Good Manufacturing Practices• Process (CI) Continuous Improvement initiatives• ERP - inventory creation, structure, costing, and routing• Root Cause Analysis• Process Mapping - manufacturing cells - (5S, TACT Time, bottlenecks, and flow optimization) • CAPA process support• Support/adherence to ISO 13485: CFR Part 820, and 14971 directives• Documentation specialist• EHS support• Feasibility Reviews• SDLC for NPI and Legacy products and CI Show less

  • Excellence Achievement Program Manager - Minnesota Regional Manager

    Apr 2017 - Aug 2018

  • Manufacturing Engineer

    Dec 2016 - Apr 2017
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  C-Axis, Inc. and C-Axis PR, Inc.

  Aug 2018 - Nov 2018

  Manufacturing and Prototype Engineering Supervisor

  • Realign of production equipment maintenance schedules and process updates• Implement Lean strategies and methodologies in troubled areas• Engineering NPI project coordination for the group• Improved coil output variation to a baseline capacity model/operator - 30% average increase• Assessing and overcoming project roadblocks and resource constraints• Lead and train with procedure and documentation updates• Execute employee reviews (360 approach) and create growth plans• Production improvement methodologies with management team• Monthly Communication meetings updating Engineering Group milestones and projects• Involved with Cost Savings Program and Safety Committee (development)• Assess new technologies and SWOT analysis for process & machine improvements• Create project plans, roadmaps, training certification, and presentations Show less

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  Biomerics Advanced Catheter Division

  Jan 2019 - Jul 2020

  Engineering Specialist

  - Development of Balloon catheters team member- Continuous Improvement for Micro Catheters (Scrap, Throughput, Efficiency, Etc.)- Micro Catheter CI and NPI engineer- R&D and Production support product engineer- GDP for legacy and NPI products, SDLC- Crossover team member and daily updates- Product Development and Design for Manufacturing- Updated multiple product line documentation (75+ docs) to align with procedure and floor operations - after 4 months yield efficiency averaged >95%- Create and drive daily metrics and throughput expectations- Pareto charts for Bottlenecks, Tact Time, and improved efficiencies- Data and trend analysis - with metrics & team - increased product output from 100/wk to 500/wk in one month Show less

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  Wilson Wolf Manufacturing Corporation

  Nov 2020 - Dec 2021

  Sr. Manufacturing Continuation Engineer Consultant
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  Cirtec Medical

  Dec 2021 - now

  Program Manager

  Custom project ownership from SOW input to project kick-off with external customers and team. Define and adhere to budget, timelines, and unknown unknowns with potential scope change.