Oliver Gottschalk

Leading global engineering experts for automation technology in medical device manufacturing. Development of standard system architectures and global automation opportunity screenings. KVP Gemba and lean manufacturing deployments. Global program lead for Best practice rollouts and automation initiatives delivering 4M$ annual savings. Validation and CSV strategies for new and systems. Requirements Engineering for automated GxP technologies. Business Case Development and Comissioning Planning. Proof of Concept new technologies. Facilitation of Workshops and Methodology Trainings.

Lead global engineering group to rollout technical standards for robotics, controls and safety delivering annual savings of 2M$. Managing globale CAPEX of 10M$ across 30+ sites. Automation of business processes & OT database architecture. Global portfolio management/ reporting for „Digital Shop floor“ Transformation. Implementation of OEE for machine and process monitoring dashboards. Facilitate Design Thinking and Innovation Workshops, SCRUM Moderation. Dynamization & digitalization of supply with eKanban. Introduction of “MRK” Robots (“CoBots”) and Autonomous Transport Vehicles (“AIVs”) in regulated production environments.

Definition, design, build, commissioning and validation of a fully automated end-2-end manufacturing platform delivering 2.5M$ annual savings. Managing global CAPEX of 6+M$. Automation of laser marking, sandblasting, 100% inspection, cleaning, galvanic, packaging under GxP and FDA regulations. Legal contract negotiations, international service agreements, requirements engineering and business case definitions. Management of multi-Level acceptance testing phases in international setting. Technology development and PoC lead for automated, deep-learning vision testing.

Potential analysis & planning of internal / external feasibility studies for process development. CNC, Pick & Place, sterile packaging. 5S, Gemba, value stream analysis (VSM/VCA). Definition of requirements specifications (URS) for automated systems. Payback and project risk analysis.

Validation project management for CNC, inspection, electroplating, titanium, welding & packaging processes. Implementation of risk-based approaches for product transfers & scope extensions management. Global expert for validation & qualification of systems. Execution of global trainings for Part 11 & ERES/ CSV validations. Audit experiences (TÜV, FDA etc.).

Final thesis “Supply chain optimization in vehicle assembly line”. Process flow analysis (VSM, REFA) to apply Just-In-Time principles for supply chain. Implement lean improvements (5S, standardization, Kanban’s & Work instructions). Quality- & project management experience.

Tutor for technical & general english for engineering students to reinforce writing, speaking and hearing with groups. Preparation of materials and agendas and autonomous teaching of lessons. Review of assignments, individual exercises.

Development of a 3D stereo projection cell for 3D real-time visualization (polarization). CAD design & bill of materials for sourcing & procurement. Assembly, setup & installation of the prototype in the interactive learning center of university campus. Experience in 3D visualization of CAD for engineering.

Interim engineering semester in the automotive industry/ Project & quality support for PPAP-Process-and Robotic Process Development/ Creation of test plans for small series & aftermarket sales production of aluminum assembly parts (car body)/ Supplier communication & coordination/ Build of an automatic production cell/ Forming processes & aftermarket sales

Production and Automation

Read Profit & Loss Statements (P&L), approveal of Capital Expenditures (CAPEX, CER) & calculation of Return on Investment (ROI), Manufacturing Cost breakdowns, Fixed & Variable Cost (DL, VL), Sales, General and Admin Overheread (SG&A), Cost of Goods Sold (COGS), Changes in Inventored Labor & Overhead (CILO), Freight-In/-Out & Raw MAterial Inventory Tracking (DII, WIP)