Steven Kotlinski

Hawthorn Woods, IL ***** 224-***-**** (M) ady7vc@r.postjobfree.com LinkedIn Profile: steve-kotlinski-a7a43a68

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 (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.

Establish technical writing guidelines and a style guide for future document creation.

Mentor internal resources regarding comprehensive writing techniques and adherence to Regulatory and Quality Standards, as well as how to tailor document information to address a wide-ranging audience.

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 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 the 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.

Patents Granted: US – 10867274, US – 11694146, 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

The above 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 Granted: 10867274 and Global – Patent Applied: EP 2791840 A4 20150729 (EN) for "System and Method for Automated Laboratory Inventory Management using RFID Technology."

US – Patent Granted: 11694116 B2 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 – Good Documentation Practices in Pharmaceutical Industries

FDA 21 CFR Part 11 – Compliance for Electronic Records, Electronic Signatures, and Data Integrity

EU MDR 2017/745 European Medical Device Regulations

IEC 60601-1 – Medical Electrical Equipment (Standard for Safety and Performance)

IEC 61000-n-n – Family of Standards for Emission and Immunity Regulations regarding Radio Frequency (RF) Energy

Product Certifications – NRTL, UL, CSA, CE Marking, EMC/EMI Regulations

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

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