Melissa Wolf Email & Phone Number

Durach, Bayern, Deutschland

• Development of custom MedTech Products from Idea to Production Implementation• Planning and Leading interdisciplinary Teams for Ramp-up and Validationprocesses in accordance to DIN EN ISO 13485, EN ISO 14971, EN 60601-1 und EN 62304 • Quoting ensuring Design to Cost (DtC), Design for Testability (DfT)• Customer oriented Compliance-, Risk and Change Control Management

Aptar Freyung Gmbh

AptarGroup (ATR), Freyung Responsibilities:• Lead the development and delivery of new custom closures for major beauty, personal care and home care Clients (i.e. Proctor & Gamble, Reckitt Benkiser, Johnson&Johnson), from conceptual design through to production. • Identify opportunities for the optimization of production processes through the application of LEAN-methods (specifically, Andon, Poka Yoke, JIT, Muda, Kaizen, Genbutsu)• Track and manage material consumption through the application of CoA and SAP • Coordinate and manage contractors across multiple, Europe-wide production facilities. • Creation of traceable product and process documentation in accordance with ISO 9001, ISO 15378 and ISO 13485 standards• Preparation and presentation of project planning, budgeting and resourcing reports to Board of Directors.Achievements:• Successfully managed the design and production of a complex closure for Proctor & Gamble on time and within budget, adding cycle-time savings of XX% and material reduction by XX% to P&Gs and €XXm to Aptars’ yearly revenue.

Carl-Zeiss-Sholarship fundingDigitalization for Smart Factory-Big Data-AI-Sensors-Smart Modular Factory DesignDigitalized Monetization Tool for allocating Environmental Impacts at SME

Rüsselsheim Am Main, Hessen, Deutschland

Lecturer in Methodical Design• Teaching the development and calculation of a balistic device (4 h/week)

Aptar Radolfzell Gmbh

AptarGroup (ATR), RadolfzellResponsibilities:• Create and maintain documented instructions for all facilities, systems, equipment and processes to ensure ongoing validation for pharmaceutical production. • Lead the Company-wide, multidisciplinary evaluation of all changes potentially influencing process reliability or product quality.• Ensure all changes proceed only if they meet the requirements of the Company’s defined Change Control Procedure.• Mentor and instruct staff across multiple production facilities in basic change control parameters and requirements• Represent the Company’s Change Control process through International Audits.• Prepare tolerance calculations / computations / assumptions for parts as required• Create or change parts, assemblies and drafts in 3d-CAD (Pro/E) as required, and manage data via Windchill and SAP.Achievements:• Successful implementation of over 50 different changes. • Representation of outcome of Change Control Processes led to certification by DQS Holding GmbH with zero-action requirement.

University Of Applied Science (Germany) & Deakin University (Australia)

AbstractThis Diploma Thesis describes the development and design of a prototype for the mass production of a small mixer for pastes (KMP). With consideration to the need to minimize production costs, the design work is made for the manufacturing of most parts utilizing injection moulding processes. Further, most electronic components for the mixer have been selected from the Chinese markets.The outcome of this Thesis is the complete 3D CAD design of a small, hand held appliance that combines, heats and mixes facial cream on demand. With this appliance, consumers can use cartridges in the form of standard pharmacy vials (10 ml and 30 ml) containing oils and hydrolates, and thereby influence and control the content, way of production, and origin of the suspo-emulsion.By the processes carried out by this appliance (combining, heating and mixing), a portion of fresh suspo-emulsion is generated and the use of preservatives can be avoided. The first two chapters set out the background context to the appliance. The first chapter details the relevant economic and market context for the appliance, as well as describing the influence of the parameters of the injection moulding process upon geometric forms. The second chapter details the key physical requirements for the appliance, through the description and analysis of functional prototypes and examples that were developed to inform the final design of the appliance. •An electrical functional protoype that proves the heating process;•a magnetic driven open-close-mechanism with a conductor coil;•a mechanical functional prototype that tested the influence of the shape of the mixer on the consitency of the suspo-emulsion; •a functional example to ensure a design which is free of leakage; •a mechanical functional prototype that tested the elasticity of a click-fastener and•a model to confirm the quantity of suspo-emulsion that is retained within the appliance during the combining, heating and mixing processes.

Diplom-Ingenieurin (Dipl.Ing.), Mechanical Engineering

Education record