Steven Kotlinski
Hawthorn Woods, IL ***** 224-***-**** (M) 847-***-**** (H) advzya@r.postjobfree.com
Professional Summary
Systems Engineer with extensive experience associated with device and system development from the concept stage through project launch; consistently recognized for performance excellence and contributions to multiple Medical Diagnostics Industry successes. Demonstrated expertise with several engineering platforms and associated areas developed from working for world-class medical companies.
Skills
Project Management
Project Organization
Problem Resolution
Process Improvement
Team and Budget Management
System Integration & Investigation
Proficiency in RFID, Magnetics, and Fluidics
Technical Research
Microsoft 365® (Office Suite)
Technical Writing; Document Review & Control
Work History
Senior Technical Writer, 06/2022 to Present
Becton, Dickinson - V. Mueller Division (TAPFIN – Contractor Role) – Vernon Hills, IL
Perform document gap analysis, reviews, updates, and rewrites to standardize Operating Procedures, Work Instructions, and other business-related documentation from six different subsidiaries & affiliates.
Principal Engineer Level 2, 06/2017 to 06/2022
Abbott Diagnostics / Abbott Informatics Solutions – Abbott Park, IL
Initiated a soft retirement due to the global health pandemic regarding international travel concerns.
Placed on medical leave with an open-ended inactive employee status.
Principal Engineer Level 2, 01/2009 to 05/2017
Abbott Diagnostics / Abbott Informatics Solutions – Abbott Park, IL
Acted as the primary Hardware System Architect and Subject Matter Expert for the AlinIQ Inventory Management System (IMS); specified RFID components, consumables, and infrastructure requirements; AlinIQ IMS was recognized as Abbott Global Diagnostics 2011 R&D Product of the Year.
Developed AlinIQ IMS User Needs, Business & Product Requirements, and translated system-level functionality derived from customer surveys, site visits, and Key Opinion Leader (KOL) forums.
Vetted preliminary IMS Product information with CFT members to formalize Project Scope, Business Plans, Implementation Schedules, and ROI to present project and concept to upper management.
Directed activities as the point-of-contact for reference lab inventory workflow analysis, RFID equipment testing protocols & data analysis, RFID inlay selection, and converted label processing.
Rewrote, updated, & migrated STARLIMS (Informatics) design documents to ADD DOORS System; established category linkages for all SWRSs (software requirement specifications), including 27 FRS (functional requirement specifications) modules with 60 new URSs (user requirement specifications).
Performed device and system-level investigations associated with performance issues and other product nonconformances (NCRs); documented cases, results, and required corrective actions in Serena Business Mashups (SBM) to ensure remediation and compliance according to Abbott QMS & CAPA Programs.
Provided SME review of Field Service and Customer-facing documentation; Installation & Service Manuals, Troubleshooting / R&R documents, and Operations Manuals with FIGS translation reviews.
Supported User Acceptance Testing (UAT) & Usability (UX) Studies for existing systems and design improvements to confirm adherence to Business & Product Requirements with results logged in SBM.
Executed technology assessments for patent investigations and Freedom-to-Operate (FTO) reviews.
Patent granted: US - 10867274 and Patent Applied: Global - EP 2791840 A4 20150729 (EN) for System and Method for Automated Laboratory Inventory Management using RFID Technology.
Senior Systems Integration Engineer Level 3, 01/2004 to 12/2008
Abbott Laboratories - Diagnostics Division – Abbott Park, IL
Managed multiple projects, support team, and budget (2.3 MM) as well as provided technical oversight for internal R&D Service Group and critical customer support activities (START - STAbilization & Response Team); directed domestic and international trade shows & any specialized Marketing projects.
Directed and participated in the first APS Workcell installations in Germany, New Zealand, Canada, and the United States; performed pre-site facility reviews and inventory process workflow assessments.
Conducted onsite support visits to resolve system-level issues at critical customer accounts worldwide.
Coordinated all project and technical aspects for installing an Accelerator APS Workcell (Acceleratour truck project); developed demo routines; demonstrations; and trained support staff (Marketing & FSEs).
Performed comprehensive rewrites of the Installation and Service Support Sections for APS Automated Workcell and Storage/Retrieval Module (SRM) Service Manual (1,200 pages combined).
Assisted Commercial and Marketing Groups with multiple aspects for supporting the market release of the i1000SR, c16000, and c4000 instrument platforms, which included worldwide customer support.
Investigated system-level boundary conditions to improve assay robustness; designed a novel magnetic particle separation circuit - an integral subsystem utilized for Alinity™ IA and BB instrument platforms.
Coordinated installation of four ci8200 IA/CC systems onto individual semi-trailers for the ARCHITour Marketing project & managed all project aspects from concept through successful country-wide demos.
Authored Installation Qualification (IQ) / Operational Qualification (OQ) procedures to qualify 125 systems to address FDA Consent Decree / CAPA observations & reviewed each completed submission.
Performed laboratory layouts and facilitated necessary infrastructure changes to transfer 125 systems from five buildings into a shared facility.
Engineer Level 4, 01/2000 to 12/2003
Associate Engineer Level 5, 01/1998 to 12/1999
Senior Engineering Technician 1, 05/1993 to 12/1997
Abbott Laboratories - Diagnostics Division – Abbott Park, IL
These roles are similar to the above job description with fewer project, managerial, planning, budgetary, and/or personnel responsibilities; and required less product-specific knowledge and/or technical expertise associated with job duty performance.
Senior Engineering Technician, 08/1992 to 04/1993
Abbott Laboratories (Butler Service Group – Contractor Role) – Abbott Park, IL
Performed design engineering activities required to develop and support benchtop configurations of the blood-typing/agglutination channel for the PRISM™ Blood Bank-Transfusion analyzer.
Technical Engineering Manager, 01/1985 to 06/1992
Baxter Healthcare - Pandex Laboratories – Mundelein, IL
Managed department resources to fulfill project requirements during prototype, pilot production, and production phases of biomedical instrumentation manufacturing; Integrity Blood Bank Analyzer, Screen Machine System (SMS), and Fluorescence Concentration Analyzer (FCA).
Provided technical support for the Engineering Review Board (ERB) for design review and Manufacturing Review Board (MRB) for production impact.
Authored and managed Company & Departmental Standard Operating Procedures (SOPs).
Developed and documented all Manufacturing assembly & test procedures and Incoming & In-Process inspection procedures for components and subsystems, respectively.
Designed required tooling, jigs, and assembly fixtures to facilitate the production of blood analyzers.
Interfaced with Engineering, Manufacturing, and Marketing to improve the manufacturability and serviceability of new designs and existing systems' reliability.
Senior Engineering Technician, 06/1974 to 12/1984
Extel Corporation – Northbrook, IL
Performed all phases of new product development and release of telecommunications equipment, including prototype assembly and test; documentation of assembly instructions and bills of materials; new product introduction; and Manufacturing personnel training.
Managed Engineering Test Lab; performed accelerated / standard life testing of components, assemblies, and systems for on-market & new teleprinter designs; documented results in formal test reports.
Supervised sixteen Manufacturing technicians and assemblers in the medium volume production and in-house / field-return repair of dot matrix teleprinters.
Education
College of Lake County – Grayslake, IL
Associate of Arts: Engineering Technology
Patents
US – Patent: 10867274 and Global – Patent Applied: EP 2791840 A4 20150729 (EN) for “System and Method for Automated Laboratory Inventory Management using RFID Technology.”
US – Patent Applied: 2021/0142261 A1 for “System and Method for Automated Laboratory Inventory Management using RFID Technology.”
Certifications
EPCglobal Member - since 10/2010
RFID Journal Member - since 01/2011
Additional Information
Certifications, Licenses, and Training:
Microsoft 365® (Office Suite)
Adobe Suite Solutions
Microsoft Teams
Microsoft SharePoint
JIRA Project Management
Agile & Scrum Methodology
Human Factors & Usability Studies
Agile Product Life-Cycle Management (APLM)
MasterControl Document Control Software
IBM Rational DOORS (Engineering Requirements Management)
Quality Function Deployment (QFD)
Serena Business Mashups (SBM)
BarTender® (Seagull Scientific) – standard barcode & RFID labeling processing software
ISO 9001 – Good Laboratory Practices (GLP) / Good Manufacturing Practices (GMP)
ISO 13485 – Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
ISO 14971 – Medical Devices - Application of Risk Management to Medical Devices
FDA 21 CFR Part 11 and Good Documentation Practices in Pharmaceutical Industries
FDA 21 CFR Part 11 Compliance for Electronic Records, Electronic Signatures and Data Integrity
Inpeco Corporation - Accelerator Automated Processing Systems FSE Training Courses
PGP Corporation - Accelerator Decision Manager Training
i2000SR Interface Module (FSE) – 04/2007 and (Operations) – 05/2007
ADD Software and Error Recovery Best Practices – 11/2006
APS Storage Module System – 06/2006
Automated (APS) Workcell and System Components – 09/2005
ARCHITECT FSE Instrument Training Courses: i1000SR – 03/2007; c8000 – 4/2003; i2000SR – 10/2001
Abbott - Six Sigma Introduction (Root Cause Analysis and DMAIC Problem Solving) – 12/2003
Abbott - I-DEAS (SDRC) Fundamentals – 02/2003
Abbott - Statistics – 04/1992
Abbott - Design of Experiments (DOE) – 06/1992
Baxter - AutoCAD Release 10 – 06/1989
Northwestern University - Thermodynamics & Statistical Mechanics – 08/1987
Shipley Associates - Professional and Technical Writing Modules – 08/1987